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Ortho Clinical Diagnostics Inc recalls VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of
Recalled November 25, 2020 · FDA recall Z-0451-2021 · Ortho Clinical Diagnostics
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 · FDA Class II
Units
691 units (OUS)
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
Description
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
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)
Manufacturer(s)
Ortho Clinical Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →