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).
Reported: March 8, 2023 Initiated: February 6, 2023 #Z-1201-2023
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.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 19 systems
- Distribution
- US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Biomerieux Inc. Units affected: 19 systems.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1201-2023.
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