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BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Recalled August 30, 2023 · FDA recall Z-2439-2023 · BioFire Diagnostics
Hazard
Due to manufacturing issue, panels may result in false negative results. · FDA Class II
Units
705 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
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →