BEUDAMED
    FDA Enforcement Class II Terminated

    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone

    Recall: Z-2085-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2085-2018
    Event ID
    79813
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    March 5, 2018
    Classification Date
    June 5, 2018
    Termination Date
    August 31, 2020
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone

    Reason

    Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

    Code Info

    All Lot Codes

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

    Quantity

    1442