# FDA recall Z-0804-2023

> **Biomerieux Inc** · Class II · device recall initiated 2022-11-09.

## Product

PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT,  CATALOG 43871

## Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0804-2023
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-09
- **Report date:** 2023-01-11

- **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-0804-2023

## Citation

> AI Analytics. FDA recall Z-0804-2023. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0804-2023. Source: US FDA. Licensed CC0.

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