MYLA Versions: 4 — Class II medical device recall Z-0084-2022
Terminated recall by BioMerieux SA, reported 2021-10-20, distributed nationwide. Under certain conditions, there is a risk for a false negative result.
| Recall number | Z-0084-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, La Balme les Grottes, N/A, France |
| Recall initiated | 2021-09-02 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2026-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IN, IT, JP, KR, NL, NO, PL, PT, SE, SG, ZA |
| Quantity | 542 units |
Product
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Reason for recall
Under certain conditions, there is a risk for a false negative result.
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-0084-2022. 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.