# FDA recall Z-3180-2018

> **bioMerieux, Inc.** · Class II · device recall initiated 2018-08-13.

## Product

VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913     Product Usage:  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. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

## Reason for recall

Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).

## Distribution

Worldwide Distribution US Nationwide and the countries of:    Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,

## Key facts

- **Recall number:** Z-3180-2018
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-13
- **Report date:** 2018-09-26
- **Termination date:** 2020-11-02

- **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-3180-2018

## Citation

> AI Analytics. FDA recall Z-3180-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3180-2018. Source: US FDA. Licensed CC0.

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