BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

Hazard

Their is a potential for false positive results when using Pneumonia panel.

Details from the source

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 Quantity: 274,290 units Lot/code info: UDI: 00815381020178/ All unexpired lots

UPC codes

00815381020178

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.