Reported Mar 7, 2018 · Terminated
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS…
Ortho Clinical Diagnostics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Clinical Diagnostics Inc · 1001 US Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- 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.
- Lot codes and dates
Lot K4852Expiration 22 Feb 2018
- Amount recalled
- 10,021 units
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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