Biomerieux MYLA Software Recall: AST Filter Errors May Not Send Results to Clinicians
Biomerieux recalls MYLA software versions 4.7 and : AST filter rules may not apply to results when sending to clinicians. Affected labs should check software version and contact Biomerieux for updates.
Lower-risk recall
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Contact the company
What happened, in plain English
Biomerieux recalls specific versions of its MYLA software (4.7 and 4.8) because AST filter rules might not apply to results when sending them to clinicians. This could lead to incorrect organism identification in lab testing. Read more at govinfonow.com/recall/58951-biomerieux-myla-software-recall-ast-filter-errors-may-not-send.
Source Summary by GovInfoNow · govinfonow.com/recall/58951-biomerieux-myla-software-recall-ast-filter-errors-may-not-send · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1201-2023
Cite this page
“Biomerieux MYLA Software Recall: AST Filter Errors May Not Send Results to Clinicians.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58951-biomerieux-myla-software-recall-ast-filter-errors-may-not-send. Based on FDA recall #Z-1201-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2023%22&limit=1).
Why it’s dangerous
The software may not correctly apply AST filter rules to results when sending them to clinicians. This could cause incorrect identification of organisms or antibiotic susceptibility, potentially affecting treatment decisions.
Who’s affected
Microbiology laboratory staff using MYLA software versions 4.7 or 4.8 with VITEK MS systems are most at risk. The recall affects labs that use this software for identifying organisms and antibiotic susceptibility testing.
How to tell if you have this one
Check if your lab uses MYLA software versions 4.7 or 4.8 with VITEK MS systems. The software connects microbiology instruments to laboratory information systems for identifying organisms and antibiotic susceptibility testing.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Check Software Version
Verify your MYLA software version is 4.7 or 4.8 to determine if it's affected.
Contact Biomerieux
Reach out to Biomerieux for guidance on updating to a newer version of the software.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, North Carolina, Puerto Rico.
Recall timeline
FDA published this recall 30 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.
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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-1201-2023 (February 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1201-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.