FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code recall
Biofire Defense recalled FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code on August 12, 2026 because of 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. It was sold nationwide.
Why it was recalled
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's 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).
Quantity: 122 kits (3,660 pouches)
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Biofire Defense, Salt Lake City, UT
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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. - Status
- Ongoing
- Recall number
- Z-2877-2026
- Source
- U.S. Food and Drug Administration
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