FDA-Device2025-12-03Class IIPROCESSING DEFECT
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
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.
Who it affects
All ages
Illnesses reported
None reported
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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