BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2476-2023
    Event ID
    92537
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    June 1, 2023
    Classification Date
    August 28, 2023
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    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.

    Code Info

    UDI-DI: 00809708121860 Siemens Material Number: 10736515 Lots: 04-23003-60 (expiry 20-Jun-2023), 11-22337-60 (expiry 20-May-2023), 04-23034-40 (expiry 21-Jul-2023), 04-23059-50 (expiry 15-Aug-2023), 04-23059-60 (expiry 15-Aug-2023), and 04-23069-40 (expiry 25-Aug-2023)

    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