Fecal Immunochemical Test Recall: Enterix InSure ONE
Announced 2025-12-10 · FDA
Enterix, Inc. is recalling InSure ONE Fecal Immunochemical Test kits, including Insure ONE POL Kit 10 pack (model 90010), 25 pack (model 90025), and InSure ONE POL Combo Pack (model 90030). These lots were produced between 7/23/2025 and 9/12/2025 and use Test Card Lot TT241102. The recall covers worldwide distribution, including the United States in listed states and the Philippines, due to failed sensitivity testing that may cause false negative results.
| Brand | Enterix, Inc. |
|---|---|
| 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. |
| Reason | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. |
| Severity | moderate |
| Units affected | 201426 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | 1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. |
WHAT YOU SHOULD DO
- Do not use any InSure ONE test kits identified in this recall.
- Check if your kit matches the recalled models (90010, 90025, 90030) and Test Card Lot TT241102; if so, discontinue use.
- Contact Enterix customer support for instructions on replacement, refund, or further guidance.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.