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Biofire Defense recalls FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Recalled March 11, 2020 · FDA recall Z-1448-2020 · Biofire Defense
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. · FDA Class III
Units
92 kits
Sold at
US: UT, MD, GA, CO, OH, TX, OUS: None
Description
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.
Product
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Manufacturer(s)
Biofire Defense
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →