FDA-Device2023-03-22Class II
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
BioFire Diagnostics, LLC
Hazard
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Sold states
U.S. Nationwide distribution in the states of FL and GA.
Affected count
2 kits
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2023Don't want to check this manually?
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