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

VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code… — recall Z-2145-2016

U.S. FDA — Device Enforcement · United Kingdom · 2016-05-09 · Class III

As described by U.S. FDA — Device Enforcement: VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2145-2016
Date of alert
2016-05-09
Country / jurisdiction
United Kingdom
Risk level
Class III
Risk type
recall
Brand
ORTHO-CLINICAL DIAGNOSTICS
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
US Nationwide Distribution
Barcode (EAN/GTIN)
10758750000876
Reported risk: Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
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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