Device product
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Z-1947-2015
Product summary
- Firm
- BioMerieux SA
- Event
- Event 71475
- Status
- Terminated
- Classification
- Class II
- Quantity
- 674
- Official record key
device-enforcement:Z-1947-2015
Official wording
Reason: QC results were out of range resulting in false resistant strains.
Code information: 1002774320, 1002377890, 1002590470, 1002775330, 1002379610
Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
Derived failure modes
-
Unknown
QC results were out of range resulting in false resistant strains.