FDA-Device2023-03-08Class II
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).
Biomerieux Inc
Hazard
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.
Sold states
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
Affected count
19 systems
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2023Don't want to check this manually?
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