MYLA software — Class II medical device recall Z-2225-2021
Terminated recall by BioMerieux SA, reported 2021-08-18, distributed nationwide. Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the B
| Recall number | Z-2225-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2021-06-22 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 248 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03573026610975, 03573026619244 |
Product
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Reason for recall
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2225-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.