FDA · Medical device recall

One Step Pregnancy Test REF 100-01 and 26 more products

Recall started May 22, 2023 · FDA enforcement report Nov. 1, 2023 Class II

Reason: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is…
Status: Ongoing
Distribution: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

Enforcement report date: Nov. 1, 2023
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by: Universal Meditech Inc.
Reason: Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
Distribution pattern: U.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan

What the record says about this device

A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.

“Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable…”One Step Pregnancy Test REF 100-01, FDA enforcement report, 2023-11-01. The caption is the record's own words.

A generic device, not the product. The mark follows the record's own words.

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: Kit, Test, Pregnancy, Hcg, Over The Counter

Distributed in (FDA's record): California Florida Illinois Louisiana New Jersey New York Texas Wyoming and nationwide

27 products in this recall

One Step Pregnancy Test REF 100-01

Product: One Step Pregnancy Test REF 100-01
Quantity: 147,000 tests
Codes and lots: Model Number: 100-01 UDI-DI Code: B512100011 Lot Numbers: 3-H25052-20UMI 3-H07102-20UMI
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Kit, Test, Pregnancy, Hcg, Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0042-2024

One Step Ovulation Test REF 200-01

Product: One Step Ovulation Test REF 200-01
Quantity: 100,000 tests
Codes and lots: Model Number: 200-01 UDI-DI Code: B512200011 Lot Numbers: 3-L12121-20UMI 3-L07102-20UMI
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0043-2024

HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

Product: HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
Quantity: 122,500 test strips
Codes and lots: Model Number: 900-10 UDI-DI Code: None Lot Numbers: URS-1-2104-01 URS-1-2102-02 URS-1-2105-01 URS-1-2106-02 URS-1-2110-02
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0044-2024

HealthyWiser UriTest" UTI Test Strips REF 900-UTI

Product: HealthyWiser UriTest" UTI Test Strips REF 900-UTI
Quantity: 5,960 test strips
Codes and lots: Model Number: 900-UTI UDI-DI Code: None Lot Numbers: URS-1-2102-03 URS-1-2106-01 URS-1-2202-01-Q URS-1-2204-01 URS-1-2207-01 URS-1-2209-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0045-2024

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

Product: HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips
Quantity: 1,500 test strips
Codes and lots: Model Number: 900-1K UDI-DI Code: Lot Numbers: URS-1-2104-02
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Nitroprusside, Ketones (Urinary, Non-Quant.)
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0046-2024

HealthyWiser pH-Aware pH 4.5…

Product: HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
Quantity: 13,000 test strips
Codes and lots: Model Number: 900-1P UDI-DI Code: None Lot Numbers: URS-1-2105-01-Q URS-1-2105-02-Q URS-1-2108-01-Q URS-1-2109-01-Q URS-1-2111-01-Q
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Dye-Indicator, Ph (Urinary, Non-Quantitative)
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0047-2024

DeTec hCG Pregnancy Urine Test Cassette Format…

Product: DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
Quantity: 4,103 cassettes (25 cassettes/box)
Codes and lots: Model Number: 100-13 UDI-DI Code: None Lot Numbers: hCG-M5-2101-01 hCG-M5-2104-01 hCG-M5-2106-01 hCG-M5-2107-01 hCG-M5-2108-01 hCG-M5-2110-01 hCG-M5-2202-01 hCG-M5-2202-02 hCG-M5-2202-03 hCG-M5-2203-01 hCG-M5-2204-01 hCG-M5-2204-02 hCG-M5-2204-03 hCG-M5-2206-01 hCG-M5-2206-02 hCG-M5-2207-01 hCG-M5-2210-02
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Visual, Pregnancy Hcg, Prescription Use
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0048-2024

Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

Product: Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
Quantity: 45,420 tests
Codes and lots: Model Number: 100-17 UDI-DI Code: Lot Numbers: hCG-MHM-2205-01 hCG-MHM-2207-01 hCG-MHM-2207-02 hCG-MHM-2207-03 hCG-MHM-2207-04 hCG-MHM-2208-01 hCG-MHM-2209-01 hCG-MHM-2209-02 hCG-MHM-2209-03 HCG-MHM-2210-01 HCG-MHM-2210-02
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Kit, Test, Pregnancy, Hcg, Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0049-2024

To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10

Product: To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
Quantity: 48 boxes (50 strips/box)
Codes and lots: Model Number: 100-13 UDI-DI Code: None Lot Numbers: hCG-S-2210-03
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Visual, Pregnancy Hcg, Prescription Use
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0050-2024

PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

Product: PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
Quantity: Unknown
Codes and lots: Model Number: 910-10 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Breast Milk-Alcohol Test System
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0051-2024

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

Product: PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
Quantity: Unknown
Codes and lots: Model Number: 200-4 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0052-2024

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

Product: PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
Quantity: Unknown
Codes and lots: Model Number: 100-4 and 200-4 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0053-2024

PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips

Product: PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
Quantity: Unknown
Codes and lots: Model Number: 100-4 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Kit, Test, Pregnancy, Hcg, Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0054-2024

PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

Product: PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Quantity: Unknown
Codes and lots: Model Number: 100-17 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Kit, Test, Pregnancy, Hcg, Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0055-2024

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Product: PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
Quantity: Unknown
Codes and lots: Model Number: 900-1KET UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Nitroprusside, Ketones (Urinary, Non-Quant.)
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0056-2024

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10

Product: PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Quantity: Unknown
Codes and lots: Model Number: 900-10 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0057-2024

DiagnosUS One Step LH Ovulation Test Strip REF 200-07

Product: DiagnosUS One Step LH Ovulation Test Strip REF 200-07
Quantity: 525 devices
Codes and lots: Model Number: 200-07 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: LH-S-2204-01-S LH-S-2111-01-S
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0058-2024

DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

Product: DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Quantity: 1,000 test
Codes and lots: Model Number: 555-10 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: COV-UL-2208-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Reagent, Coronavirus Serological
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0059-2024

DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07

Product: DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07
Quantity: 2,400 tests
Codes and lots: Model Number: 210-07 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: FSH-S-2106-01 FSH-S-2108-01 FSH -S-2111-01-S
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Radioimmunoassay, Follicle-Stimulating Hormone
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0060-2024

Lem Fertility hCG Pregnancy Urine Test REF 100-12

Product: Lem Fertility hCG Pregnancy Urine Test REF 100-12
Quantity: 2,500 tests
Codes and lots: Model Number: 100-12 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: hCG -S-2112-02
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Visual, Pregnancy Hcg, Prescription Use
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0061-2024

Lem Fertility LH Ovulation Test (Strip) REF 200-07

Product: Lem Fertility LH Ovulation Test (Strip) REF 200-07
Quantity: 12,500 tests
Codes and lots: Model Number: 200-07 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: LH-S-2112-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0062-2024

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Product: DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
Quantity: 5,025 tests
Codes and lots: Model Number: 100-12 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: hCG-S-2101-01 hCG-S-2111-01-S hCG-S-2112-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Visual, Pregnancy Hcg, Prescription Use
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0063-2024

DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

Product: DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
Quantity: 25,000 cassettes
Codes and lots: Model Number: 100-13 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: hCG-M5-2103-01 hCG-M5-2106-02 hCG- M5-2109-01 hCG- M5-2203-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Visual, Pregnancy Hcg, Prescription Use
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0064-2024

DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

Product: DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
Quantity: 1,000 cassettes
Codes and lots: Model Number: 100-27 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: hCG-M5-2106-03
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Visual, Pregnancy Hcg, Prescription Use
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0065-2024

DiagnosUS Pregnancy Test Midstream REF 100-17

Product: DiagnosUS Pregnancy Test Midstream REF 100-17
Quantity: 3,304 tests
Codes and lots: Model Number: 100-17 UDI-DI Code: 710928980000 Lot Numbers: All products manufactured after March 2021 to include: hCG-M11-2103-01 hCG-M11-2105-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Kit, Test, Pregnancy, Hcg, Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0066-2024

DiagnosUS Ovulation Predictor Midstream REF 200-17

Product: DiagnosUS Ovulation Predictor Midstream REF 200-17
Quantity: 3,600 tests
Codes and lots: Model Number: 200-17 UDI-DI Code: 697691538914 Lot Numbers: All products manufactured after March 2021 to include: LH-M11-2101-01 LH-M11-2105-01 LH-M11-2106-01 LH-M11-2107-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0067-2024

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Product: OMTMO One Step Ovulation (LH) Test Strips REF 200-07
Quantity: 40,000 strips
Codes and lots: Model Number: 200-07 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021 to include: LH-S-2108-01
Recall started: May 22, 2023
Voluntary or mandated: Voluntary: Firm initiated
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): Other
What the company told customers: On 06/07/2023, the firm emailed customers to inform them of the intent of the firm to recall all products we have sold to them in the past two years; in that email, UMI has advised them to immediately stop further distribution of any product that was made by UMI. In the past few weeks, UMI has conducted a thorough investigation of their order information. We will send formal recall letters to them with all the batch information of all products they have ordered since March 2021. On 06/30/2023, the firm sent via US Certified Post, a hard copy letter of it first version of the recall notification. On 09/02/2023, the firm sent an updated "URGENT: MEDICAL DEVICE RECALL" letter via email to inform customers that Universal Meditech Inc. is going out of business hence would not be able to continue fulfilling any post-market responsibilities for these distributed products. Therefore, the firm decided to recall any products that have not yet been sold to end users. Customers are being advised to immediately stop distributing or using any of the abovementioned devices in your remaining stock. If you have already distributed the device to any other distributors or retailors, we kindly ask you to inform them of the product recall by forwarding this letter to them. Please kindly acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending it back to us. For questions, contact Michael M. Lin, Legal Attorney at 702-871-9888 (9AM to 5PM, PST, MON to FRI) or email ml@linlawgroup.com Firm issued a Press Release - posting at www.universal-meditech.com Update Information (09/15/2023): On 09/17/2023, additional "URGENT: MEDICAL DEVICE RECALL" Letter were sent via email and FedEx, to inform customer of additional products added to the Recall and to indicated that products being recalled are for any products that have not been used and instructing customers to notify customers that they have further distributed the products
Recall number: Z-0068-2024

This recall among the others

FDA's enforcement report came 163 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
Universal Meditech: 1 other recall or notice on this site in the three years before this one (from Nov. 1, 2020).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement reports, recall numbers Z-0042-2024, Z-0043-2024, Z-0044-2024, Z-0045-2024, Z-0046-2024, Z-0047-2024, Z-0048-2024, Z-0049-2024 and others. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record

FDA recall record Z-0042-2024, Nov. 1, 2023. "One Step Pregnancy Test REF 100-01 and 26 more products." PlainRecords, https://plainrecords.com/recall/device/z-0042-2024/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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