Recall Z-1201-2023 ยท OUG Medical Device Data System
Biomerieux Inc
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).
| Date | Mar 2, 2023 (initiated Feb 6, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | BioMerieux, US subsidiary issued an URGENT FIELD SAFETY NOTICE to its consignees beginning on 02/06/2023 by email and letter. The notice explained the issue with the product and potential risk, and requested the use take the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. If you are using VITEK MS as part of your laboratory workflow AND you currently use MYLA AST Filter rules disable current MYLA AST Filter rules. Review AST results to determine if some results should be suppressed from reporting. 3. I |
| Quantity | 19 systems |
| Distribution | US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.