Medical Device Recall: FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
BioFire Diagnostics, LLC · December 14, 2023
Reason for Recall
Their is a potential for false positive results when using Pneumonia panel.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
274,290 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0994-2024
Status: ongoing
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