BioMerieux VITEK 2 Software Versions 8.01-9.03 Recall: Software Anomalies Risk
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.
Lower-risk recall
There are 7 reported software anomalies that may affect use of the device.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60368-biomerieux-vitek-2-software-versions-8-01-9-03-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/60368-biomerieux-vitek-2-software-versions-8-01-9-03-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1640-2022
Cite this page
“BioMerieux VITEK 2 Software Versions 8.01-9.03 Recall: Software Anomalies Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60368-biomerieux-vitek-2-software-versions-8-01-9-03-recall. Based on FDA recall #Z-1640-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
BioMerieux- Product
bioMerieux, Inc. recalls VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8- Category
Medical device
What to do — step by step
Check Software Version
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).
How this recall unfolded
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I tell if I have the recalled software?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-1640-2022 (July 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1640-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.