FilmArray NGDS Warrior Panel
Biofire Defense recalls FilmArray NGDS Warrior Panel due to strain mismatches affecting test accuracy.
If you use the FilmArray NGDS Warrior Panel, discontinue use of affected lots and contact Biofire Defense for instructions on returning the product and obtaining a replacement.
Recall at a glance
- Quantity recalled
- 122 kits (3,660 pouches)
Why it was recalled
Biofire Defense is recalling the FilmArray NGDS Warrior Panel, a qualitative multiplexed nucleic acid-based in vitro diagnostic test for use with the FilmArray 2.0 system, because the firm identified mismatches between the outbreak strain and the reference strain used in the test's development. The panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids from human whole blood (EDTA).
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The
- Lot code
- 311825D, 312025D, 313526D, 322925D
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification