FDAJuly 10, 2025device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
FDA enforcement status: Ongoing
Brands named
biofire defensebiofire
UPCs
00851458005136
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.2026-04-22
- FDABiofire Spotfire Respiratory/Sore Throat Panel REF: 4234852026-04-01
- FDABioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)2025-10-22
- FDABioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems2025-04-30
- FDAFilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-03742025-02-27
- FDAFILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U2024-08-07
- FDAFILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W2024-08-07
- FDABIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 4108532024-06-19
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