Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure Recalled by Enterix, Inc. Due to InSure ONE failed sensitivity testing when used with...
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 Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
Quantity: 201,426 test kits
Why Was This Recalled?
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
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