FDA · Medical device recall

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry… and 3 more products

July 23, 2025 Class II

Date: July 23, 2025
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
Filed by: Ortho-Clinical Diagnostics, Inc.
Reason: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.

4 products in this recall

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I…

Product: Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
Quantity: 37429 units (US)/11,703 units (OUS)
Codes and lots: Lot Code: Product Code: 806 7324 (UDI: 10758750004317) Lots currently within expiry: V1665 - Exp.8/14/2025 B2245 - Exp 3/25/2026 Y2110 - Exp. 3/25/2026 E2828 - Exp. 2/3/2027
Recall started: June 10, 2025
Device type: Colorimetry, Cholinesterase
Root cause (FDA): Under Investigation by firm
What the company told customers: On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid reconstitution location until the issue has been resolved. " Please forward this notification if the affected products were distributed outside of your facility. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization. QuidelOrtho's investigation is ongoing, and we are working to identify root cause. We will communicate again after root cause has been determined and the issue has been resolved. Please note that until this issue is resolved, future lots of VITROS Performance Verifiers I and II may not meet the 7-day reconstituted stability for CHE. DISTRIBUTORS: REQUIRED ACTIONS " Please send the enclosed customer letter and customer Confirmation of Receipt form to all customers who have been shipped VITROS Chemistry Products Performance Verifiers AND VITROS CHE Slides from August 1, 2023, to date. " Complete the enclosed distributor Confirmation of Receipt form no later than June 18, 2025. " Please forward this notification if the affected products were distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Recall number: Z-2120-2025

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II…

Product: Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
Quantity: 36005 Units (US)/22,302 units OUS
Codes and lots: Lot Code: Product Code: 823 1474 (UDI: 10758750004577) Lots currently within expiry: W1667- Exp. 8/14/2025 X1901 - Exp. 11/20/2025 A2114 - Exp. 3/25/2026 D2338 - Exp. 6/3/2026 F2830 - Exp. 2/3/2027
Recall started: June 10, 2025
Device type: Colorimetry, Cholinesterase
Root cause (FDA): Under Investigation by firm
What the company told customers: On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid reconstitution location until the issue has been resolved. " Please forward this notification if the affected products were distributed outside of your facility. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization. QuidelOrtho's investigation is ongoing, and we are working to identify root cause. We will communicate again after root cause has been determined and the issue has been resolved. Please note that until this issue is resolved, future lots of VITROS Performance Verifiers I and II may not meet the 7-day reconstituted stability for CHE. DISTRIBUTORS: REQUIRED ACTIONS " Please send the enclosed customer letter and customer Confirmation of Receipt form to all customers who have been shipped VITROS Chemistry Products Performance Verifiers AND VITROS CHE Slides from August 1, 2023, to date. " Complete the enclosed distributor Confirmation of Receipt form no later than June 18, 2025. " Please forward this notification if the affected products were distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Recall number: Z-2121-2025

VITROS Chemistry Products CHE Slides…

Product: VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Quantity: 27, 330 US/ 19,679,730 OUS
Codes and lots: Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); UDI-DI: (1) 10758750000241, (2) 10758750004225; Lot Numbers: All lots within expiry.
Recall started: June 10, 2025
Device type: Colorimetry, Cholinesterase
Root cause (FDA): Under Investigation by firm
What the company told customers: On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid reconstitution location until the issue has been resolved. " Please forward this notification if the affected products were distributed outside of your facility. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization. QuidelOrtho's investigation is ongoing, and we are working to identify root cause. We will communicate again after root cause has been determined and the issue has been resolved. Please note that until this issue is resolved, future lots of VITROS Performance Verifiers I and II may not meet the 7-day reconstituted stability for CHE. DISTRIBUTORS: REQUIRED ACTIONS " Please send the enclosed customer letter and customer Confirmation of Receipt form to all customers who have been shipped VITROS Chemistry Products Performance Verifiers AND VITROS CHE Slides from August 1, 2023, to date. " Complete the enclosed distributor Confirmation of Receipt form no later than June 18, 2025. " Please forward this notification if the affected products were distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Recall number: Z-2122-2025

VITROS Chemistry Products CHE Slides (Japan)…

Product: VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Quantity: 414,000 (OUS)
Codes and lots: Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides); UDI-DI: (1) 10758750030293, (2) 10758750030309; Lot Numbers: All lots within expiry.
Recall started: June 10, 2025
Device type: Colorimetry, Cholinesterase
Root cause (FDA): Under Investigation by firm
What the company told customers: On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid reconstitution location until the issue has been resolved. " Please forward this notification if the affected products were distributed outside of your facility. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization. QuidelOrtho's investigation is ongoing, and we are working to identify root cause. We will communicate again after root cause has been determined and the issue has been resolved. Please note that until this issue is resolved, future lots of VITROS Performance Verifiers I and II may not meet the 7-day reconstituted stability for CHE. DISTRIBUTORS: REQUIRED ACTIONS " Please send the enclosed customer letter and customer Confirmation of Receipt form to all customers who have been shipped VITROS Chemistry Products Performance Verifiers AND VITROS CHE Slides from August 1, 2023, to date. " Complete the enclosed distributor Confirmation of Receipt form no later than June 18, 2025. " Please forward this notification if the affected products were distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Recall number: Z-2123-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2120-2025, Z-2121-2025, Z-2122-2025, Z-2123-2025. The agency record governs; check it and the company before acting.

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