medical Class II Updated 2021-06-30

BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Recalled Product

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Hazard / Issue

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
View official government recall

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