FDA recall Z-1518-2025

BioFire Diagnostics, LLC · Class II · device

Product

FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

Reason for recall

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

Distribution

OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel

Key facts

Status
Ongoing
Initiation date
2025-02-27
Report date
2025-04-16
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-1518-2025