BEUDAMED
    FDA Enforcement Class II Terminated

    RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

    Recall: Z-1008-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-1008-2022
    Event ID
    89898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 4, 2022
    Initiation Date
    March 9, 2022
    Classification Date
    April 26, 2022
    Termination Date
    January 22, 2025
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

    Reason

    Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.

    Code Info

    Date of manufacture: 2021-11

    Distribution

    US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI

    Quantity

    81 registered accounts