medical Class II Updated 2024-02-14

BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00815381020178/ All unexpired lots
View official government recall

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