Biomerieux recalls ETEST Vancomycin M100 US due to potential performance issues from temperature and time exposure. Affected units include specific batch numbers and catalog codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling ETEST Vancomycin M100 US products because they may not work correctly if stored or used outside recommended temperature and time ranges. This could lead to inaccurate test results in clinical settings.
The product's performance can become unreliable if it is exposed to temperatures or time conditions outside the manufacturer's specified range. This may cause inaccurate test results in clinical settings.
Healthcare professionals using the ETEST Vancomycin M100 US products for clinical testing are most likely affected. Patients relying on accurate test results may be impacted if the product fails.
Check for the catalog number 423788 and batch numbers starting with 1009351550 on the product label. The product is sold under the brand Biomerieux.
Look for the catalog number 423788 and batch numbers starting with 1009351550 on the product label.
The product may not work correctly if stored or used outside recommended temperature and time ranges, which could lead to inaccurate test results.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
Check for the catalog number 423788 and batch numbers starting with 1009351550 on the product label.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0860-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0860-2023 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.
