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BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Recalled February 14, 2024 · FDA recall Z-0994-2024 · BioFire Diagnostics
Hazard
Their is a potential for false positive results when using Pneumonia panel. · FDA Class II
Units
274,290 units
Sold at
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.
Description
Their is a potential for false positive results when using Pneumonia panel.
Product
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →