Brand
Enterix
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Enterix and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-10FDA-DeviceClass IIInSure 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.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
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