Ortho-Clinical recalls VITROS SARS-CoV-2 Antigen Reagent Packs that may produce false positive results when used with Remel M4RT Viral Transport Media. Affected kits must be checked for specific product codes and lot numbers.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
Ortho-Clinical is recalling VITROS SARS-CoV-2 Antigen Reagent Packs that can give false positive results when used with Remel M4RT Viral Transport Media. This could lead to incorrect test results and unnecessary anxiety or actions.
The test kit may produce false positive results when used with Remel M4RT Viral Transport Media. This could lead to incorrect conclusions about SARS-CoV-2 infection, potentially causing unnecessary follow-up tests or actions.
Healthcare providers and labs using the VITROS SARS-CoV-2 Antigen Reagent Packs with Remel M4RT Viral Transport Media are most at risk of false positive results.
Check for product code 6199941 and any lot numbers used with Remel M4RT Viral Transport Media. The kit is labeled as 'Emergency Authorization Use Only (EAU)' and has a unique identifier UDI: 10758750033584.
Look for product code 6199941 on the kit label.
Ensure the kit was not used with Remel M4RT Viral Transport Media.
The VITROS SARS-CoV-2 Antigen Reagent Pack may produce false positive results when used with Remel M4RT Viral Transport Media.
Check if the kit was used with Remel M4RT Viral Transport Media and verify the product code 6199941. If it was used with the transport media, contact Ortho-Clinical for guidance.
The test kit is safe to use with other transport media, but may give false positives with Remel M4RT Viral Transport Media.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1267-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1267-2021 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.
