Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Recalled by BioFire Diagnostics, LLC Due to The firm has identified an increased risk of...
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 (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Quantity: 61,069
Why Was This Recalled?
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ 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