FDASeptember 17, 2025device
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 qualitative...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
What to do
FDA enforcement status: Ongoing
Brands named
enterix
UPCs
108500930033132085009300331000850093003279
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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