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BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i
Recalled January 17, 2024 · FDA recall Z-0703-2024 · BioFire Diagnostics
Hazard
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission. · FDA Class II
Units
53 Kits
Sold at
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Description
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
Product
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →