Reported Oct 27, 2021 · Terminated
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance…
Ortho Clinical Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2
- Product Code6199966
- Lot codes and dates
- Lot Number0040(*and
- potentially future lots) UDI10758750034475 Exp
- Date19NOV2021
- Amount recalled
- US: 64 OUS: 200
Where it was sold
Why it was recalled
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
This product could cause temporary or reversible health problems — stop using it.
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