# FDA recall Z-1534-2020

> **bioMerieux, Inc.** · Class II · device recall initiated 2020-02-05.

## Product

VITEK 2 card AST-N371 - Product Usage: The 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

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

## Distribution

International distribution in the countries of Germany and the Netherlands.

## Key facts

- **Recall number:** Z-1534-2020
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-05
- **Report date:** 2020-04-01
- **Termination date:** 2022-10-28

- **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-1534-2020

## Citation

> AI Analytics. FDA recall Z-1534-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1534-2020. Source: US FDA. Licensed CC0.

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