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Ortho-Clinical Diagnostics, Inc. recalls VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used
Recalled March 24, 2021 · FDA recall Z-1267-2021 · Ortho-Clinical Diagnostics
Hazard
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media · FDA Class II
Units
12177 units
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Canada L3R 4G5, Chile, Colombia, Denmark, France, Germany, India, Italy, Japan, Portugal, Russia, Singapore 609917, Spain, United Kingdom.
Description
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
Product
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product.
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →