FDA-Device2020-03-11Class III
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
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.
Sold states
US: UT, MD, GA, CO, OH, TX, OUS: None
Affected count
92 kits
Manufactured in
79 W 4500 S, Ste 14, Salt Lake City, UT, United States
Products
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2020Don't want to check this manually?
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