Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
VITROS Chemistry Products Performance Verifier is used as an assayed Recalled by Ortho Clinical Diagnostics Inc Due to VITROS Performance Verifier II (PVII) Lot K4852 does...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho Clinical Diagnostics Inc directly.
Affected Products
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Quantity: 10,021 units
Why Was This Recalled?
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
Where Was This Sold?
Worldwide
About Ortho Clinical Diagnostics Inc
Ortho Clinical Diagnostics Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report