FDA Enforcement
Class II
Ongoing
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Recall: Z-2609-2025
·
Reported October 1, 2025
Enforcement
- Recall Number
- Z-2609-2025
- Event ID
- 97286
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Biofire Defense
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 1, 2025
- Initiation Date
- July 10, 2025
- Classification Date
- September 19, 2025
- Address
- 79 W 4500 S Ste 14, N/A, Salt Lake City, UT, 84107-2663, United States
Description
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Reason
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Code Info
UDI-DI: 00851458005136. Lot(Expiration): 324324D(2026-02-19), D241022(2026-01-22), 319524D(2025-11-20), 315424D(2025-10-09), 315224D(2025-10-03), 315324D(2025-10-08)
Distribution
US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.
Quantity
130 Kits