Enterix

2 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment

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.

Class I - Dangerous

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Sep 17, 2025 Diagnostic Equipment Nationwide View Details →

InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.

Class I - Dangerous

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

Oct 8, 2020 Diagnostic Equipment Nationwide View Details →