Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 Recalled by BioFire Diagnostics, LLC Due to Due to temperature excursions with products (products being...
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
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Quantity: 2 kits
Why Was This Recalled?
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
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