Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient…

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

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.

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 be returned for sorting and destruction.

• FDA enforcement recordOfficial FDA database entry for Z-0725-2026
• FDA 510(k) clearance · K170548The device's official FDA premarket clearance record
• FDA device classification · KHEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.6550The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Enterix, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.