Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 Recalled by BioFire Diagnostics, LLC Due to Due to potential signals of increased false positive...
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 RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
Quantity: 64,594 kits (equals 2,303,760 tests)
Why Was This Recalled?
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) 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