Z-1201-2023 Class II Ongoing
FDA device recall Z-1201-2023 was initiated by Biomerieux Inc on February 6, 2023 and is designated Class II. 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 recall status is ongoing. Affected quantity: 19 systems.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- February 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 systems
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.
Distribution Pattern
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
Code Information
Versions 4.7 and 4.8