Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) Recalled by Enterix, Inc. Due to Product does not meet internal testing criterion; use...
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 Enterix, Inc. directly.
Affected Products
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Quantity: US: 5,256 vials (131,400 test strips); OUS:1051 vials
Why Was This Recalled?
Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Enterix, Inc.
Enterix, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report