FDA recall Z-1201-2023

Biomerieux Inc · Class II · 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).

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

US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2023-02-06
Report date
2023-03-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2023