BioMerieux SA recalls Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

Recall date

June 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1947-2015

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

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, Ind…

Why it was recalled

QC results were out of range resulting in false resistant strains.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.