Recall Z-1201-2023— Biomerieux Inc
Class II · Ongoing
Class II FDA medical device recall by Biomerieux Inc, initiated 2023-02-06. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-06
- Firm location
- Hazelwood, MO, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.