FilmArray NGDS Warrior Panel
The FilmArray NGDS Warrior Panel has mismatches between the outbreak strain and the reference strain used in its development.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Biofire Defense of Salt Lake City, Utah, is recalling its FilmArray NGDS Warrior Panel REF NGDS-ASY-0007, a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system, because the firm has identified mismatches between the outbreak strain and the reference strain used in the development of the panel.
The test detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).
The recall began July 16, 2026, and was added to the FDA's Enforcement Report on August 4, 2026. The product was distributed nationwide 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 recall covers 122 kits (3,660 pouches).
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The
- UDI-DI
- 00851458005136
- Lot
- 311825D
- 312025D
- 313526D
- 322925D
Details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of 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 and Washington.
- Event ID
- 99459
- Recall No.
- Z-2877-2026
- Company
- Biofire DefenseSalt Lake City, Utah
- Hazard
- Device defect
- Quantity recalled
- 122 kits (3,660 pouches)
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
