# FDA recall Z-0243-2022

> **bioMerieux, Inc.** · Class II · device recall initiated 2021-09-30.

## Product

API 50 CH, Model 50300

## Reason for recall

There is potential to provide an incorrect organism identification.

## Distribution

Distribution in WI, NY, and SD

## Key facts

- **Recall number:** Z-0243-2022
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-30
- **Report date:** 2021-11-24
- **Termination date:** 2024-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2022

## Citation

> AI Analytics. FDA recall Z-0243-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0243-2022. Source: US FDA. Licensed CC0.

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