Home / Recalls / Medical Devices
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/35
Recalled March 7, 2018 · FDA recall Z-0807-2018 · Ortho Clinical Diagnostics
Hazard
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. · FDA Class III
Units
10,021 units
Sold at
Worldwide
Description
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.
Product
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.
Manufacturer(s)
Ortho Clinical Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →