Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FilmArray Gastrointestinal (GI) Panel Recalled by BioFire Diagnostics, LLC Due to Elevated rates of false positive results for Campylobacter...
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 Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Quantity: 17188
Why Was This Recalled?
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
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