BioMerieux SA recalls ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the an…

Recall date

April 25, 2017

Source

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

Recall number

Z-2095-2017

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY

Why it was recalled

False susceptible results

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 ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)