FDA-Device2021-06-30Class II
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
BioFire Diagnostics, LLC
Hazard
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
Sold states
US nationwide distribution
Affected count
870 kits
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1903-2021Don't want to check this manually?
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