medical Class II Updated 2023-08-30

BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For

Recalled Product

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only


Hazard / Issue

Due to manufacturing issue, panels may result in false negative results.

Issued by

FDA

Affected States: CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, TN, UT, WV
Lot/Code Info: Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482
View official government recall

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