# FDA recall Z-1137-2019

> **bioMerieux, Inc.** · Class II · device recall initiated 2019-03-15.

## Product

Biomerieux Vitek 2 Test kit     VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

## Reason for recall

Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.

## Distribution

Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

## Key facts

- **Recall number:** Z-1137-2019
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-15
- **Report date:** 2019-04-24
- **Termination date:** 2021-08-17

- **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-1137-2019

## Citation

> AI Analytics. FDA recall Z-1137-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1137-2019. Source: US FDA. Licensed CC0.

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