Reported Aug 12, 2026 · Ongoing
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a…
Biofire Defense
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biofire Defense · 79 W 4500 S Ste 14 · Salt Lake City, UT · 84107-2663
Is this the product you have?
- 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)
- Lot codes and dates
- Part NumberNGDS-ASY-0007
- UDI-DI code(01)00851458005136
- Lot Numbers311825D 312025D 313526D 322925D
- Amount recalled
- 122 kits (3,660 pouches)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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