Device 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).
Z-1201-2023
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 91617
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 systems
- Official record key
device-enforcement:Z-1201-2023
Official wording
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.
Code information: Versions 4.7 and 4.8
Distribution pattern: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
Derived failure modes
-
Unknown
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.