United StatesThe FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 (UDI-DI (01)00851458005136; Part Number NGDS-ASY-0007; Lot numbers 311825D, 312025D, 313526D, 322925D) is a qualitative, multiplex nucleic acid in vitro diagnostic test for use with the FilmArray 2.0 system that detects Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus from human whole blood (EDTA). BioFire Defense is recalling these kits because the firm identified mismatches between the outbreak strain and the reference strain used in the panel’s development.
What's being recalled
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).
Recalling firm: Biofire Defense, Salt Lake City, UT, United States.
How to identify it
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
The hazard
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)