Biomerieux recalls VIDAS CMV IgM 30 Tests with calibration issues in specific lots. Affected units may give inaccurate results; stop using and contact for replacement.
bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
Biomerieux is recalling certain lots of VIDAS CMV IgM 30 Tests due to calibration problems that could lead to inaccurate results. This affects lab tests for CMV (cytomegalovirus) infections.
The calibration issues in specific lots can cause inaccurate test results for cytomegalovirus (CMV) infections. This may lead to incorrect diagnoses or treatment decisions.
Lab users who purchased the recalled lots of VIDAS CMV IgM 30 Tests are affected. Healthcare professionals and labs using these specific lots for testing are most at risk.
Check for lot numbers 1008143230, 1008182270, 1008363970, or 1008433580 with expiration dates listed above. The product is sold under US reference 30205-01.
Look for lot numbers 1008143230, 1008182270, 1008363970, or 1008433580 on the test kit packaging.
Reach out to Biomerieux for a replacement or refund if you have the recalled lot numbers.
Biomerieux received complaints about calibration issues in specific lots of VIDAS CMV IgM 30 Tests.
Lot numbers 1008143230 (exp. 04 MAY 2021), 1008182270 (exp. 26 MAY 2021), 1008363970 (exp. 01 SEP 2021), and 1008433580 (exp. 15 OCT 2021).
No immediate stop is required, but you should contact Biomerieux if you have the recalled lot numbers for a replacement.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1408-2021 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1408-2021 from Biomerieux. 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.
