Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1201-2023 — 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).

U.S. FDA — Device Enforcement · United States · 2023-02-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1201-2023
Date of alert: 2023-02-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1201-2023 — 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).

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