PlainRecordsSimplexa COVID-19 Direct… and 1 more product
- Reason
- Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
- Status
- Ongoing
- Distribution
- US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
- Enforcement report date
- March 15, 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
- DiaSorin Molecular LLC
- Reason
- Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
- Distribution pattern
- US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
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.
“Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.”Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2, FDA enforcement report, 2023-03-15. 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: Reagents, 2019-Novel Coronavirus Nucleic Acid
Distributed in (FDA's record): Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Missouri Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Vermont Virginia Washington West Virginia Wisconsin and nationwide
2 products in this recall
Simplexa COVID-19 Direct…
- Product
- Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
- Quantity
- 90142
- Codes and lots
- UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot: MOL4150/US13950/MOL4151/US14091, MOL4150/US14913/MOL4151/US14063, MOL4150/US13952/MOL4151/US14065, MOL4150/US13955/MOL4151/US14086, MOL4150/US13959/MOL4151/US14088, MOL4150/US13956/MOL4151/US14087, MOL4150/US13960/MOL4151/US14093, MOL4150/US13961/MOL4151/US14094, MOL4150/US13973/MOL4151/US13732, MOL4150/US13974/MOL4151/US13736, MOL4150/US14006/MOL4151/US13738, MOL4150/US14004/MOL4151/US15064, MOL4150/US14005/MOL4151/US13737, MOL4150/US14008/MOL4151/US14100, MOL4150/US14007/MOL4151/US14099, MOL4150/US14010/MOL4151/US14102, MOL4150/US14011/MOL4151/US14103, MOL4150/US14012/MOL4151/US15290, MOL4150/US14018/MOL4151/US14111, MOL4150/US14009/MOL4151/US14101, MOL4150/US14017/MOL4151/US14109, MOL4150/15061N/MOL4151/13474N, MOL4150/X15475N/MOL4151/X15479N, MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/13967N/MOL4151/15082N
- Recall started
- Jan. 30, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Reagents, 2019-Novel Coronavirus Nucleic Acid
- Root cause (FDA)
- Device Design
- What the company told customers
- On 01/30/2023, correction notices were distributed to customers via in-person site visits. Customers were asked to do the following: 1) Discontinue use of affected devices using affected assay definitions. 2) Customers can contact the recalling firm to replace affected kits. The firm can also provide assistance with inventory reconciliation/destruction, and if needed, assistance with potential instrument/lab decontamination. 3) Any sample result with an error code (EC510, EC515, RNA IC, Insufficient Specimen Volume) should be retested following the Instructions for Use. 4) If leakage is suspected, the spillage should be removed and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. 5) This recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Notify others within your network that may have remaining inventory of those kits. 5) Complete and return the acknowledgement and receipt form and return to the recalling firm's Technical Service department at technicalinfo.molecular@diasorin.com Product in the field with the previous high spin assay definitions are being recalled and replaced with current products with the current reduced spin assay definitions. Customers with questions are encouraged to email (see above) or call Technical Service at (800) 838-4548, option 3, Monday - Friday, 7:00am to 5:00pm (Pacific Time)
- Recall number
- Z-1209-2023
Simplexa Flu A/B & RSV Direct Gen II…
- Product
- Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
- Quantity
- 4142
- Codes and lots
- UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N
- Recall started
- Jan. 30, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Respiratory Virus Panel Nucleic Acid Assay System
- Root cause (FDA)
- Device Design
- What the company told customers
- On 01/30/2023, correction notices were distributed to customers via in-person site visits. Customers were asked to do the following: 1) Discontinue use of affected devices using affected assay definitions. 2) Customers can contact the recalling firm to replace affected kits. The firm can also provide assistance with inventory reconciliation/destruction, and if needed, assistance with potential instrument/lab decontamination. 3) Any sample result with an error code (EC510, EC515, RNA IC, Insufficient Specimen Volume) should be retested following the Instructions for Use. 4) If leakage is suspected, the spillage should be removed and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. 5) This recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Notify others within your network that may have remaining inventory of those kits. 5) Complete and return the acknowledgement and receipt form and return to the recalling firm's Technical Service department at technicalinfo.molecular@diasorin.com Product in the field with the previous high spin assay definitions are being recalled and replaced with current products with the current reduced spin assay definitions. Customers with questions are encouraged to email (see above) or call Technical Service at (800) 838-4548, option 3, Monday - Friday, 7:00am to 5:00pm (Pacific Time)
- Recall number
- Z-1210-2023
This recall among the others
- FDA's enforcement report came 44 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).
- DiaSorin Molecular: 3 other recalls or notices on this site in the three years before this one (from March 15, 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-1209-2023, Z-1210-2023. 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-1209-2023, March 15, 2023. "Simplexa COVID-19 Direct… and 1 more product." PlainRecords, https://plainrecords.com/recall/device/z-1209-2023/ (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