BioMerieux SA recalls API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some minia…

Recall date

January 8, 2016

Source

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

Recall number

Z-0756-2016

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY

Why it was recalled

Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.

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

What was recalled

API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.