BioMérieux recalls VITEK 2 Systems and VITEK 2 with MYLA due to software issues causing incorrect antibiotic screen and synergy test results in lab systems. Affected units include specific versions.
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
BioMérieux is recalling VITEK 2 Systems and VITEK 2 with MYLA because software errors may lead to incorrect antibiotic test results in lab systems. This could affect the accuracy of critical medical testing if not corrected.
The software sends test results to lab information systems (LIS) without including user-corrected or AES-corrected interpretations. This means the final test results might be inaccurate, potentially leading to incorrect treatment decisions for patients.
Laboratory users with VITEK 2 Systems or VITEK 2 with MYLA software versions 8.01, 9.01, 9.02, 9.03, or 4.8/4.9 are most at risk. These systems are used for antibiotic screening and synergy testing in clinical labs.
Check if your VITEK 2 System or VITEK 2 with MYLA has software versions 8.01, 9.01, 9.02, 9.03 (with or without 9MR2), or 4.8/4.9. These versions were sold between 2019 and 2020.
Identify your VITEK 2 System or VITEK 2 with MYLA software version to confirm if it is affected.
Affected versions include VITEK 2 - 8.01, 9.01, 9.02, 9.03 (with or without 9MR2), and VITEK 2 with MYLA - 4.8 and 4.9.
The software issue may cause incorrect antibiotic screen and synergy test results in lab information systems, potentially leading to inaccurate treatment decisions.
The recall does not require immediate discontinuation; users should check their software version and 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-1059-2022 — BioMérieux BioMérieux Hello, I own a BioMérieux that is covered by recall Z-1059-2022 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.
