# FDA recall Z-1201-2023

> **Biomerieux Inc** · Class II · device recall initiated 2023-02-06.

## 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

- **Recall number:** Z-1201-2023
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-06
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1201-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1201-2023. Source: US FDA. Licensed CC0.

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