BioMérieux recalls VIDAS CMV IgM 30-test kits with invalid calibrations that may cause inaccurate results. Affected lots expire June 2022.
Invalid calibrations (out of range high) while using the product.
BioMérieux is recalling VIDAS CMV IgM 30-test kits that may have invalid calibrations, leading to inaccurate results. This could affect medical testing for CMV infections.
The kits may have calibrations outside the acceptable range, causing inaccurate test results. This could lead to incorrect conclusions about CMV infections, especially in critical medical decisions.
Healthcare providers using these kits for CMV testing are affected. Patients relying on accurate test results may be at risk of incorrect diagnoses.
Check for lot number 1008873260 on the kit packaging. These kits were sold with an expiration date of June 2:2022.
Look for lot number 1008873260 on the product packaging.
The kits may have invalid calibrations (out of range high) that can cause inaccurate test results.
Check for lot number 1008873260 on the packaging; these kits expire June 2022.
The recall does not specify a remedy, so contact BioMérieux for guidance.
We’ve drafted a message you can send BioMérieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0742-2022 — BioMérieux BioMérieux Hello, I own a BioMérieux that is covered by recall Z-0742-2022 from BioMérieux. 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.