# FDA recall Z-1742-2020

> **Biomerieux Inc** · Class II · device recall initiated 2020-03-11.

## Product

The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

## Reason for recall

There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403).     .

## Distribution

No distribution within the United States.   Foreign distribution locations: Netherlands, Luxembourg, Belgium

## Key facts

- **Recall number:** Z-1742-2020
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-11
- **Report date:** 2020-04-29

- **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-1742-2020

## Citation

> AI Analytics. FDA recall Z-1742-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1742-2020. Source: US FDA. Licensed CC0.

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