Biofire Defense: Device Recall
Recall #Z-2609-2025 · 07/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2609-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Biofire Defense
- Status
- Ongoing
- Date Initiated
- 07/10/2025
- Location
- Salt Lake City, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 Kits
Reason for Recall
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.
Product 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.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.