BioMerieux MYLA Software Recall: Unwanted Result Alterations Risk
BioMerieux recalls MYLA software versions 4.7.0-4.8.1 for potential unwanted result alterations when using BCI Connect. Affected users should contact for remedy.
Use caution until it’s fixed
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Contact the company
What happened, in plain English
BioMerieux is recalling specific versions of their MYLA software used in microbiology labs. The software could alter test results if certain conditions are met while using the BCI Connect feature. Read more at govinfonow.com/recall/62314-biomerieux-myla-software-recall-unwanted-result-alterations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62314-biomerieux-myla-software-recall-unwanted-result-alterations-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2225-2021
Cite this page
“BioMerieux MYLA Software Recall: Unwanted Result Alterations Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62314-biomerieux-myla-software-recall-unwanted-result-alterations-risk. Based on FDA recall #Z-2225-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2225-2021%22&limit=1).
Why it’s dangerous
The software anomaly can apply unwanted changes to test results when using the BCI Connect scripting feature under specific conditions. This could lead to incorrect medical decisions if results are used for patient care.
Who’s affected
Microbiology lab staff and healthcare facilities using MYLA software versions 4.7.0-4.8.1 with BCI Connect. Those handling medical test results are most at risk.
How to tell if you have this one
Check if you have MYLA software versions 4.7.0, 4.7.1, 4.8.0, or 4.8.1 installed with BCI Connect. The software was sold with UDI numbers 03573026619244 and 03573026610975.
- Brand
BioMerieux- Category
Medical device
What to do — step by step
Check Software Version
Identify if your MYLA software is version 4.7.0, 4.7.1, 4.8.0, or 4.8.1 installed with BCI Connect.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution in the U.S. was nationwide. There was also military and government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-2225-2021 (June 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2225-2021 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.