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BioMerieux SA recalls Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Recalled July 8, 2015 · FDA recall Z-1947-2015 · BioMerieux SA
Hazard
QC results were out of range resulting in false resistant strains. · FDA Class II
Units
674
Sold at
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.
Description
QC results were out of range resulting in false resistant strains.
Product
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Manufacturer(s)
BioMerieux SA
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →