BioMerieux recalls MYLA software versions 4.7 through 4.8.2 for potential false negative results in testing. Affected users should contact the company for updates.
Under certain conditions, there is a risk for a false negative result.
BioMerieux is recalling specific versions of their MYLA software (4.7 through 4.8.2) due to a risk of false negative results in testing. This means the software might incorrectly show a test as negative when it's actually positive, which could lead to missed diagnoses.
The software may produce false negative results under certain conditions, meaning tests that should be positive might appear negative. This could lead to missed diagnoses if the software fails to detect a condition that is actually present.
Users of the MYLA software versions 4.7 through 4.8.2 in the VIRTUO System are affected. Healthcare professionals using this software for diagnostic testing are most at risk.
Check if you have MYLA software versions 4.7, 4.7.1, 4.8, 4.8.1, or 4.8.2 as part of the VIRTUO System. The software is used in medical diagnostic testing equipment.
Reach out to BioMerieux for guidance on whether your software version is affected and what steps to take next.
The recall is for a potential false negative result, which could lead to missed diagnoses. However, the risk is not described as causing serious injury or death, so it's considered low risk.
You have the affected software if you own MYLA versions 4.7, 4.7.1, 4.8, 4.8.1, or 4.8.2 as part of the VIRTUO System.
Contact BioMerieux directly for guidance on whether your software version is affected and what steps to take next.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0084-2022 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-0084-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
