medical Class II Updated 2025-04-16

BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-03

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Lot/Code Info: UDI: 00815381020314/Lot# 0979424
View official government recall

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