FDA-Device2024-08-28Class II
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
BioFire Diagnostics, LLC
Hazard
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Sold states
Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
Affected count
24 Kits
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2683-2024Don't want to check this manually?
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