Biomerieux product recalled over mold contamination

Recall date

January 23, 2018

Source

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

Official notice title

Biomerieux Inc recalls bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent…

Recall number

Z-2874-2018

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV

Why it was recalled

Missing desiccant.

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

What was recalled

bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.