FDA-Device2023-08-30Class II
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
BioFire Diagnostics, LLC
Hazard
Due to manufacturing issue, panels may result in false negative results.
Sold states
US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
Affected count
24 Kits (30 pouches/kit)
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2023Don't want to check this manually?
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