BioMerieux SA recalls
Every recall we track for BioMerieux SA — 14 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from BioMerieux SA peaked in 2018 (11); 14 since 2017.
All FDA recall records for BioMerieux SA since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 6 | 5 | 11 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 1 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled BioMerieux SA product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All BioMerieux SA recalls
6 shown- Lower riskMedical device
BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
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.
BioMerieuxSep 2, 2021 - Use cautionMedical device
BioMerieux SA recalls MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results
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.
BioMerieuxJun 22, 2021 - Lower riskMedical device
BioMerieux SA recalls NucliSENS¿ Magnetic Extraction Reagents
BioMerieux recalls NucliSENS Magnetic Extraction Reagents from specific lots due to potential performance issues from low temperatures. Affected units may not function correctly if stored in cold environments.
BioMerieuxSep 17, 2018 - Lower riskMedical device
BioMerieux SA recalls VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of
BioMerie: VIDAS FSH test (Ref 30407-01) recalled due to potential invalid calibration with low calibrator S1. Affected units distributed in the U.S. with lot #1005888210.
BioMerieuxApr 9, 2018 - Lower riskMedical device
BioMerieux SA recalls The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as
BioMerieux recalls VITEK 2 Gram Positive Susceptibility Cards due to potential temperature excursions affecting lab results. Products shipped to Guadeloupe were exposed to 47.8°C in July 2017, leading to quarantine and delayed delivery.
BioMerieuxMar 23, 2018 - Lower riskMedical device
BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675
BioMerieux recalls specific lot of NucliSENS Lysis Buffer Extended for RES 76675 due to potential test inhibition from heme residue, risking inaccurate PCR results.
BioMerieuxOct 18, 2017
BioMerieux SA recall questions
How many recalls has BioMerieux SA had?
14 recalls from BioMerieux SA are on record with U.S. safety agencies, from 2017–2021.
What is the most recent BioMerieux SA recall?
BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System, dated Sep 2, 2021. Every BioMerieux SA recall is listed on this page, newest first.
What should I do if I have a recalled BioMerieux SA product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new BioMerieux SA recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.