BioMerieux MYLA Software Recall: Unwanted Result Alterations Risk

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Recalling firmBioMerieux SAChemin De L'Orme, N/A · Marcy L'Etoile, N/A N/A

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

What versions of MYLA software are affected?

MYLA software versions 4.7.0, 4.7.1, 4.8.0, and 4.8.1 with BCI Connect.

How can I tell if I have the affected software?

Check for UDI numbers 03573026619244 or 03573026610975 on the software installation.

What should I do if I have the affected software?

The recall record does not specify a remedy, so contact BioMerieux for guidance.

Take action

Contact BioMerieux

We’ve drafted a message you can send BioMerieux to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2225-2021 — BioMerieux BioMerieux

Hello,

I own a BioMerieux that is covered by recall Z-2225-2021 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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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.

BioMerieux SA recalls MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results

Use caution until it’s fixed