# FDA recall Z-0264-2018

> **BioMerieux SA** · Class II · device recall initiated 2017-04-13.

## Product

ETEST OXACILLIN OX 256 US F100        In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.

## Reason for recall

QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.

## Distribution

Worldwide Distribution - USA (nationwide) and to the countries of :  Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.

## Key facts

- **Recall number:** Z-0264-2018
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-13
- **Report date:** 2017-12-27
- **Termination date:** 2020-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marcy L'Etoile, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2018

## Citation

> AI Analytics. FDA recall Z-0264-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0264-2018. Source: US FDA. Licensed CC0.

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