BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 1, 2022

    Recall

    Recall Number
    Z-1372-2022
    Event Number
    90432
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 1, 2022
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    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.

    Action

    Siemens has issued an Urgent Medical Device Correction letter POC 22-010.A.US via FedEx beginning on June 1, 2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: Please dispose any inventory of epoc BGEM test card lot 11-22005-50 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of this product and assess your laboratory s replacement needs. Please use an epoc BGEM test card from another unaffected lot. Review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter. Please retain this letter with your laboratory records and forward it to those who may have received this product. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

    Distribution

    AL CA CO FL IA ID KS NM OK TX

    Quantity

    263 Boxes