MYLA comprises AST Filters in conjunction with VITEK MS — Class II medical device recall Z-1201-2023
Ongoing recall by Biomerieux Inc, reported 2023-03-08, distributed nationwide. For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filte
| Recall number | Z-1201-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2023-02-06 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 19 systems |
Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Reason for recall
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
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-1201-2023. 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.