FDA-Device2025-12-03Class II
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
BioFire Diagnostics, LLC
Hazard
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Sold states
US Nationwide distribution in the states of ID, OR, AZ.
Affected count
23 kits (690 pouches)
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0602-2026Don't want to check this manually?
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