Reported Oct 1, 2025 · Ongoing
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test…
Biofire Defense
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biofire Defense · 79 W 4500 S Ste 14 · Salt Lake City, UT · 84107-2663
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI00851458005136
- 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)
- Amount recalled
- 130 Kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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