Recall Z-0725-2026 ยท KHE Reagent, Occult Blood
Enterix, Inc.
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.
| Date | Nov 28, 2025 (initiated Sep 17, 2025) |
| Status | Open, Classified |
| Reason | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. |
| Root cause | Under Investigation by firm |
| Action | Consignees were initially sent an email as notification of the recall on about 09/17/2025, which was followed by a formal recall notification letter on about 09/23/2025. Consignees were instructed to immediately examine inventory and quarantine any affected units, notify customers if affected further distributed, and for those patients that have already been tested using an InSure ONE test kit that has been identified as part of the scope of this recall be retested. Once an inventory count has been received by Enterix, they will provide RMA and courier information so the recalled product can |
| Quantity | 201,426 test kits |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170548 | InSure ONE Enterix, Inc., Oct 5, 2017 |