# FDA recall Z-2226-2021

> **Biomerieux Inc** · Class II · device recall initiated 2021-06-24.

## Product

ETEST IMIPENEM RELEBACTAM.  in vitro diagnostic

## Reason for recall

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of  Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.

## Key facts

- **Recall number:** Z-2226-2021
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-24
- **Report date:** 2021-08-18
- **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-2226-2021

## Citation

> AI Analytics. FDA recall Z-2226-2021. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2226-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*