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

Recalled June 30, 2021 · FDA recall Z-1944-2021 · BioFire Diagnostics

Hazard

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

Units

9 kits (U.S. only)

Sold at

U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None

Description

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

Product

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

Manufacturer(s)

BioFire Diagnostics, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →