Z-0265-2018 Class II Terminated
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
ETEST OXACILLIN OX 256 WW 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 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.
Code Information
REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110.