FDA-Device2021-06-30Class II
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
BioFire Diagnostics, LLC
Hazard
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Sold states
U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Affected count
9 kits (U.S. only)
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief