# FDA recall Z-2225-2021

> **BioMerieux SA** · Class II · device recall initiated 2021-06-22.

## Product

MYLA software.  Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.

## Reason for recall

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

## Distribution

Distribution in the U.S. was nationwide.  There was also military and government distribution.

## Key facts

- **Recall number:** Z-2225-2021
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-22
- **Report date:** 2021-08-18
- **Termination date:** 2023-02-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marcy L'Etoile, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2021

## Citation

> AI Analytics. FDA recall Z-2225-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2225-2021. Source: US FDA. Licensed CC0.

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