FDAAugust 20, 2019device
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
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
- FDAFilmArray 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.2025-07-10
- 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
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