RecallWatchUSA

Home / Recalls / Medical Devices

BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

Recalled February 14, 2024 · FDA recall Z-0993-2024 · BioFire Diagnostics

Hazard
Their is a potential for false positive results when using Pneumonia panel. · FDA Class II
Units
214,080 pouches
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 Plus (Pneumoplus), REF: RFIT-ASY-0143, 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