BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-0725-2026 · Initiated September 17, 2025

    Recall

    Recall Number
    Z-0725-2026
    Event Number
    97802
    Firm
    Enterix, Inc.
    FEI Number
    3003224146
    Product Code
    KHE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 17, 2025
    Posted
    November 28, 2025
    Address
    236 Fernwood Ave, Edison, NJ, 08837-3839

    Description

    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.

    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 be returned for sorting and destruction.

    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.

    Quantity

    201,426 test kits