Z-2877-2026 Class II Ongoing
FDA device recall Z-2877-2026 was initiated by Biofire Defense on July 16, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 122 kits (3,660 pouches).
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- July 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122 kits (3,660 pouches)
Product Description
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).
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D