Recall Z-2609-2025 ยท PRD
Biofire Defense
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.
| Date | Sep 19, 2025 (initiated Jul 10, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | On 7/10/2025, correction notices were mailed and emailed to customers who were asked to do the following: - If testing with only whole blood and/or sputum, there is no impact to the product s performance. Continue using panel kits as planned. - If testing with positive blood culture may occur, discontinue use, dispose of impacted kit(s) according to your lab s procedures, and only use replacement kits provided, or use impacted lots only with whole blood and/or sputum sample types. - Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and |
| Quantity | 130 Kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170883 | FilmArray NGDS Warrior Panel Biofire Defense, LLC, Jun 22, 2017 |