FDA Device recall Z-1201-2023
MYLA comprises AST Filters in conjunction with VITEK MS
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of MYLA comprises AST Filters in conjunction with VITEK MS by Biomerieux, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1201-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-06 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
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 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.
Identifiers
| code_info | Versions 4.7 and 4.8 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2023%22
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