Ortho-Clin: VITROS SARS-CoV-2 Antigen Reagent may give false positive results when used with Remel M4RT Viral Transport Media. Recalled for safety.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
Ortho-Clinical's VITROS SARS-CoV-2 Antigen Reagent may produce false positive results when used with Remel M4RT Viral Transport Media. This could lead to incorrect COVID-19 test results.
The reagent may give false positive results when used with Remel M4RT Viral Transport Media. This could lead to incorrect COVID-19 test results, potentially causing unnecessary isolation or treatment.
People using the VITROS SARS-CoV-2 Antigen Reagent with Remel M4RT Viral Transport Media for at-home or lab testing. Those testing with the specific combination are most at risk.
Check if the VITROS SARS-CoV-2 Antigen Reagent was used with Remel M4RT Viral Transport Media. The product code is 6199949 and UDI is 10758750033584.
Verify if the VITROS SARS-CoV-2 Antigen Reagent was used with Remel M4RT Viral Transport Media.
The VITROS SARS-CoV-2 Antigen Reagent may produce false positive results when used with Remel M4RT Viral Transport Media.
Check if you used the reagent with Remel M4RT Viral Transport Media. If so, stop using it and contact Ortho-Clinical for guidance.
The recall does not provide a fix; users must check usage and stop using the reagent if it was used with Remel M4RT.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1266-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1266-2021 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
