FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: recall (Biofire Defense)
Medical deviceClass IIOngoing
Summary: Biofire Defense is recalling 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 Bacil. Reason: 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 is 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).
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
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. (states named: Alabama, California, District of Columbia, Florida, Georgia, Hawaii, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, Nevada, New York, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington)
How to tell if yours is affected
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2877-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 16, 2026 |
| Reported | August 12, 2026 |
| Company | Biofire Defense |
| Company location | Salt Lake City, UT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 122 kits (3,660 pouches) |
More recalls from Biofire Defense · all medical device recalls · recalls from July 2026