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FilmArray® NGDS Warrior Panel
BIOFIRE DEFENSE, LLC · Model NGDS-ASY-0007 · UDI-DI 00851458005136
1
510(k) clearances
0
Adverse events
3
Recalls
1
Facilities
Description
FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-16 | Biofire Defense | Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic |
| 2025-07-10 | Biofire Defense | 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 additiona |
| 2019-08-20 | Biofire Defense | The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit. |
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