medical Class II Updated 2020-11-25

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

Recalled Product

VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

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: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20

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