Product Wiki · Recalls · U.S. FDA — Device Enforcement

VITROS Chemistry Products Performance Verifier is used as an assayed… — recall Z-0807-2018

U.S. FDA — Device Enforcement · United States · 2017-07-10 · Class III

As described by U.S. FDA — Device Enforcement: 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 Inte

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0807-2018
Date of alert
2017-07-10
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Ortho Clinical Diagnostics Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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