FDAFDA · Food and drugs·Recall number Z-0264-2018
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Published December 27, 2017 · Recall initiated: April 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioMerieux SA
- Distributor
- 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.
- Lot
- REF: 520558, Lot numbers: 1003059010, 1003315830, 1004071250, 1004818860 and 1004890400.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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