BEUDAMED
    FDA Enforcement Class II Ongoing

    epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515

    Recall: Z-1372-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1372-2022
    Event ID
    90432
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    June 1, 2022
    Classification Date
    July 12, 2022
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637, United States

    Description

    epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515

    Reason

    Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

    Code Info

    UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022

    Distribution

    AL CA CO FL IA ID KS NM OK TX

    Quantity

    263 Boxes