# FDA recall Z-0422-2022

> **Biomerieux Inc** · Class II · device recall initiated 2021-11-09.

## Product

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

## Reason for recall

There is an error in the new version of the package insert.  The Reading Table lists the incorrect color for a negative result for the CIT test.

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI.  There was government distribution but no military distribution.

## Key facts

- **Recall number:** Z-0422-2022
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-09
- **Report date:** 2022-01-05
- **Termination date:** 2025-02-10

- **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-0422-2022

## Citation

> AI Analytics. FDA recall Z-0422-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0422-2022. Source: US FDA. Licensed CC0.

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