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BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Recalled August 30, 2023 · FDA recall Z-2440-2023 · BioFire Diagnostics
Hazard
Due to manufacturing issue, panels may result in false negative results. · FDA Class II
Units
24 Kits (30 pouches/kit)
Sold at
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
Description
Due to manufacturing issue, panels may result in false negative results.
Product
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →