FDA-Device2024-02-14Class II
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
BioFire Diagnostics, LLC
Hazard
Their is a potential for false positive results when using Pneumonia panel.
Sold states
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.
Affected count
274,290 units
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0994-2024Don't want to check this manually?
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