FDA-Device2025-10-01Class II
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.
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.
Sold states
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.
Affected count
130 Kits
Manufactured in
79 W 4500 S Ste 14, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2609-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief