Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in co

Is my product affected?

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. 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 q

• UPC 10758750033584

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

What happened

Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent because the product can produce false reactive results when used with Remel M4RT Viral Transport Media. The recall affects 2,782 units of any lot used with Remel M4RT VTM (UDI: 10758750033584) that were distributed worldwide, including throughout the United States and in countries including Australia, Belgium, Canada, Chile, Colombia, Denmark, France, Germany, India, Italy, Japan, Portugal, Russia, Singapore, Spain, and the United Kingdom.

The recall record does not specify a remedy or what affected consumers should do.

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: 2782 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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