MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology ...
FDA Recall #Z-1201-2023 — Class II — February 6, 2023
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.
Recalling Firm
Biomerieux Inc — Hazelwood, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
19 systems
Distribution
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
Code Information
Versions 4.7 and 4.8
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated