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BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Recalled April 16, 2025 · FDA recall Z-1518-2025 · BioFire Diagnostics
Hazard
Increased risk of control failures and false negative test results with multiplexed nucleic acid test. · FDA Class II
Units
29 kits
Sold at
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Description
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →