BEUDAMED
    FDA Recall Open, Classified

    epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

    Recall: Z-2476-2023 · Initiated June 1, 2023

    Recall

    Recall Number
    Z-2476-2023
    Event Number
    92537
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 1, 2023
    Posted
    August 28, 2023
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

    Reason

    There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

    Action

    Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.

    Distribution

    US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam

    Quantity

    3201 ea