Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FilmArra Pneumonia Panel plus (Pneumoplus) Recalled by BioFire Diagnostics, LLC Due to Increased risk of control failures and false negative...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioFire Diagnostics, LLC directly.
Affected Products
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Quantity: 29 kits
Why Was This Recalled?
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Where Was This Sold?
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
About BioFire Diagnostics, LLC
BioFire Diagnostics, LLC has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report