FDASeptember 10, 2021device
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 Quant...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
What to do
FDA enforcement status: Terminated
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
10758750034475
Recall history
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