Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 Recalled by BioFire Diagnostics, LLC Due to Elevated rates of false positive/false negative and control...
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 (Penumo) REF RFIT-ASY-0144
Quantity: 9 kits (U.S. only)
Why Was This Recalled?
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
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