medical Class II Updated 2020-11-25

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

Recalled Product

VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)


Hazard / Issue

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number/ Exp. Date: 0110 25-NOV-20
View official government recall

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