FDA Medical devices recall ·
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed… recall
- Recall number
- Z-2609-2025
- Date
- (initiated July 10, 2025)
- Company / brand
- Biofire Defense
79 W 4500 S Ste 14, Salt Lake City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 130 Kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alabama Arizona California District of Columbia Florida Hawaii Iowa Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina New Hampshire Nevada New York Ohio Rhode Island Tennessee Texas Utah Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2609-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.