FilmArray Gastrointestinal Panel recalled over fire hazard

Recall date

March 6, 2019

Source

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

Official notice title

BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), P…

Recall number

Z-1242-2019

FDA classification

Class II

Brand / firm

BioFire Diagnostics, LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: CO, IL, NJ, PA, OH, FL, KY, NE, NY, CA, WV, UT, TX, MS, OK, WI, NC, DE, IN, MN, AK, ND, GA, AR, MO, KS, HI, IA, LA, VA, SC, MT, NM, SD, AL, WY, AZ, WA, TN, OR, MI, MA, NV, MD, CT, DC, VT, ID, NH, RI, ME. Foreign (OUS): Argentina, Austria, Aus…

Why it was recalled

Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.

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

What was recalled

FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.