BioMerieux recalls MYLA software versions 4.7 through 4.8.2 for potential false negative results in testing. Affected users should contact the company for updates.
Under certain conditions, there is a risk for a false negative result.
Take action
Contact the company
📍Recalling firmBioMerieux SA3 route de Port Michaud · La Balme les Grottes, France
✎ GovInfoNow plain-language explainer
BioMerieux is recalling specific versions of their MYLA software (4.7 through 4.8.2) due to a risk of false negative results in testing. This means the software might incorrectly show a test as negative when it's actually positive, which could lead to missed diagnoses. Read more at govinfonow.com/recall/61843-biomerieux-myla-software-versions-4-7-4-8-2-recall.
“BioMerieux MYLA Software Versions 4.7-4.8.2 Recall: False Negative Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61843-biomerieux-myla-software-versions-4-7-4-8-2-recall. Based on FDA recall #Z-0084-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0084-2022%22&limit=1).
The FDA announced on 2021-09-02 that BioMerieux SA is recalling MYLA software versions 4.7 through 4.8.2, part of the VIRTUO System, due to a risk of false negative results. The recall affects 542 units distributed worldwide.
How to tell if you have it
Brand: BioMerieux
Product: MYLA Software versions 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2 (part of the VIRTUO System)
Quantity: 542 units
The hazard
Under certain conditions, there is a risk for a false negative result.
Context
GovInfoNow's records show BioMerieux SA has 5 other recalls on record since 2017-10-18. Other recent recalls of similar products include BioMerieux MYLA Software Recall (2021-06-22), BioMerieux NucliSENS Magnetic Extraction Reagents Recall (2018-09-17) and BioMerieux VIDAS FSH Test Recall (2018-04-09). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04) and BioFire Respiratory Panel 2.1 Recall (2025-10-22).
How to tell if you have this one
Check if you have MYLA software versions 4.7, 4.7.1, 4.8, 4.8.1, or 4.8.2 as part of the VIRTUO System. The software is used in medical diagnostic testing equipment.
Brand
BioMerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact BioMerieux
Reach out to BioMerieux for guidance on whether your software version is affected and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 4.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall is for a potential false negative result, which could lead to missed diagnoses. However, the risk is not described as causing serious injury or death, so it's considered low risk.
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-0084-2022 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0084-2022 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.