medical Class II Updated 2021-10-27

Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantit

Recalled Product

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 Code: 6199966


Hazard / Issue

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021
View official government recall

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