FDA recall Z-2440-2023

BioFire Diagnostics, LLC · Class II · device

Product

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

Reason for recall

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

Distribution

US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

Key facts

Status
Ongoing
Initiation date
2023-05-08
Report date
2023-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2023