FDASeptember 30, 2020device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
10758750033362
Recall history
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