Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FilmArray Pneumonia Panel Plus (Pneumoplus) Recalled by BioFire Diagnostics, LLC Due to Their is a potential for false positive results...
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
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Quantity: 214,080 pouches
Why Was This Recalled?
Their is a potential for false positive results when using Pneumonia panel.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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