FDA-Device2021-08-18Class II
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
BioFire Diagnostics, LLC
Hazard
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Sold states
U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
Affected count
29 kits
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2245-2021Don't want to check this manually?
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