Ortho-Clinical Diagnostics, Inc.: VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnosti

Is my product affected?

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 nucleo

• UPC 10758750033584

Check against the official notice below — it lists the full affected range.

What happened

Ortho-Clinical Diagnostics, Inc. is recalling the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack because it can produce false reactive results when used with Remel M4RT Viral Transport Media. The affected product was distributed worldwide, including throughout the United States and in countries such as Canada, Australia, France, Germany, Japan, and the United Kingdom. A total of 12,177 units were involved in the recall, specifically any lot of the reagent pack used in combination with Remel M4RT VTM.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media

Details from the source

Reason for recall: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media Distribution: 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. Quantity: 12177 units Lot/code info: Any lot used with Remel M4RT VTM UDI: 10758750033584

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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