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Recall Observatory FDA recall evidence

Device 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.

Z-2609-2025

July 10, 2025

Class II

Product summary

Firm
Biofire Defense
Event
Event 97286
Status
Ongoing
Classification
Class II
Quantity
130 Kits
Official record key
device-enforcement:Z-2609-2025

Official wording

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 information: 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 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.