BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382

    Recall: Z-2970-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2970-2020
    Event ID
    86378
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2020
    Initiation Date
    August 28, 2020
    Classification Date
    September 14, 2020
    Termination Date
    September 9, 2021
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    Description

    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382

    Reason

    Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

    Code Info

    Lot Number: 01-20095-10

    Distribution

    Nationwide Foreign: Canada

    Quantity

    463 boxes (50 test cards/box )