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Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001
Recalled December 10, 2025 · FDA recall Z-0725-2026 · Enterix
Hazard
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. · FDA Class II
Units
201,426 test kits
Sold at
Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.
Description
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Product
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.
Manufacturer(s)
Enterix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →