Reported Mar 8, 2023 · Ongoing
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments…
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- 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).
- Lot codes and dates
- Versions 4.7 and 4.8
- Amount recalled
- 19 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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