Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products Recalled by Ortho-Clinical Diagnostics, Inc. Due to VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics, Inc. directly.
Affected Products
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.
Quantity: 12177 units
Why Was This Recalled?
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report