Z-0264-2018 Class II Terminated
FDA device recall Z-0264-2018 was initiated by BioMerieux SA on April 13, 2017 and is designated Class II. 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… The recall status is terminated (terminated August 18, 2020). Affected quantity: 1585 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2017
- Initiation Date
- April 13, 2017
- Termination Date
- August 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1585 units
Product Description
Reason for Recall
Distribution Pattern
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.