Safety Alert: Class II: 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.
healthClass IIRecalled on Oct 1, 2025
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmAr
🔢 130 Kits
Sold At: Biofire Defense(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.)
Recall #: FDA-DEVICE-Z-2609-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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)
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Summary
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 to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Biofire Defense for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.