BEUDAMED
    FDA Enforcement Class II Ongoing

    Detector H. Pylori, Catalog Number IHP-30

    Recall: Z-0702-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0702-2024
    Event ID
    93646
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Immunostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 17, 2024
    Initiation Date
    August 25, 2023
    Classification Date
    January 10, 2024
    Address
    38 Industrial Way E Ste 1, Eatontown, NJ, 07724-3334, United States

    Description

    Detector H. Pylori, Catalog Number IHP-30

    Reason

    Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.

    Code Info

    UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31

    Distribution

    Product distributed to CA and MO.

    Quantity

    10 kits