BEUDAMED
    FDA Enforcement Class II Terminated

    InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.

    Recall: Z-0590-2021 · Reported December 23, 2020

    Enforcement

    Recall Number
    Z-0590-2021
    Event ID
    86674
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Enterix, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 23, 2020
    Initiation Date
    October 8, 2020
    Classification Date
    December 15, 2020
    Termination Date
    January 10, 2023
    Address
    236 Fernwood Ave, N/A, Edison, NJ, 08837-3839, United States

    Description

    InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.

    Reason

    Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy

    Code Info

    Lot Numbers: 770G11 and 770G21

    Distribution

    Worldwide distribution - US Nationwide and the country of Australia.

    Quantity

    US: 5,256 vials (131,400 test strips); OUS:1051 vials