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Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in
Recalled October 1, 2025 · FDA recall Z-2609-2025 · Biofire Defense
Hazard
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup. · FDA Class II
Units
130 Kits
Sold at
US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.
Description
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Product
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Manufacturer(s)
Biofire Defense
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →