Recall Z-2877-2026 ยท PRD
Biofire Defense
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 vir
| Date | Aug 4, 2026 (initiated Jul 16, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 07/16/2026, an "ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION" Letter was sent via FedEx Priority Overnight to customer informing them that, due to the emergence of the 2026 Bundibugyo outbreak strain, BioFire Defense has conducted testing to evaluate performance of the Orthoebolavirus spp. assays on the FilmArray NGDS Warrior Panel. This preliminary testing has identified a potential reduction in sensitivity to the 2026 Bundibugyo outbreak strain which could result in Orthoebolavirus spp. Not Detected results when testing on the FilmArray NGDS Warrior Panel. Customers are instructed |
| Quantity | 122 kits (3,660 pouches) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170883 | FilmArray NGDS Warrior Panel Biofire Defense, LLC, Jun 22, 2017 |