Class II

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

BioFire Diagnostics, LLC · February 27, 2025

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

Quantity Affected

29 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1518-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.