# FDA recall Z-0525-2022

> **Biomerieux Inc** · Class II · device recall initiated 2021-12-20.

## Product

API ID 32 C Strips, Reference 32200, Rx Only, IVD    API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.

## Reason for recall

Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.

## Distribution

US (Domestic) Distribution to states of: AZ, IA, KY, and NY.

## Key facts

- **Recall number:** Z-0525-2022
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-20
- **Report date:** 2022-02-02
- **Termination date:** 2023-09-25

- **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-0525-2022

## Citation

> AI Analytics. FDA recall Z-0525-2022. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0525-2022. Source: US FDA. Licensed CC0.

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