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BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Recalled June 4, 2025 · FDA recall Z-1877-2025 · BioFire Diagnostics
Hazard
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. · FDA Class II
Units
30 kits
Sold at
International distribution in the country of Singapore.
Description
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →