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Recall Observatory FDA recall evidence

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

February 06, 2023

Class II

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

    reason.no_named_rule · v1.0.0

    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.