FDA-Device2025-06-04Class II
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
BioFire Diagnostics, LLC
Hazard
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Sold states
International distribution in the country of Singapore.
Affected count
30 kits
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1877-2025Don't want to check this manually?
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