Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BIOFIRE FILMARRAY Pneumonia Panel plus Recalled by BioFire Diagnostics, LLC Due to Pneumonia panels have an increased risk of 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
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Quantity: 24 Kits
Why Was This Recalled?
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
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