BioMerieux recalls VITEK 2 software versions 8.01-9.03 and MYLA versions V4.8-V4.9 for 7 reported software anomalies that may affect veterinary use. Affected units have specific UDI/GTIN numbers.
There are 7 reported software anomalies that may affect use of the device.
BioMerieux is recalling specific software versions for veterinary use. These versions have 7 reported software anomalies that could affect device operation. Users should check their software version and contact BioMerieux if affected.
The software versions have 7 reported anomalies that could affect device operation. These anomalies may cause incorrect results or system errors during veterinary testing. The hazard is limited to software issues rather than physical damage.
Veterinary labs and professionals using the VITEK 2 system with the recalled software versions. Those with the specific UDI/GTIN numbers listed are most at risk.
Check if your VITEK 2 software is version 8.01, 8.02, 9.01, 9.02, or 9.03 (veterinary use only). Also check if your MYLA software is version V4.8 or V4.9. The affected units have specific UDI/GTIN numbers listed in the recall.
Review your VITEK 2 software version and MYLA software version to see if they match the recalled versions (8.01-9.03 for VITEK 2, V4.8-V4.9 for MYLA).
VITEK 2 software versions 8.01, 8.02, 9.01, 9.02, 9.03 (veterinary use only) and MYLA software versions V4.8, V4.9.
Check your software version and UDI/GTIN numbers. Affected units have specific UDI/GTIN numbers listed in the recall: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568.
The recall does not specify a remedy, so no action is required unless you want to update to a newer software version.
We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1640-2022 — BioMerieux BioMerieux Hello, I own a BioMerieux that is covered by recall Z-1640-2022 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.
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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.
