BEUDAMED
    FDA Recall 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 · Initiated March 9, 2022

    Recall

    Recall Number
    Z-1008-2022
    Event Number
    89898
    Firm
    Roche Diabetes Care, Inc.
    FEI Number
    3011393376
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 9, 2022
    Terminated
    January 22, 2025
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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.

    Action

    Urgent Medical Device Correction Notice 22-001 was issued March 09, 2022 via email. The software issue was resolved with the cloud-based software update to version 2.5.5 on February 24, 2022. No further action required. Customers to submit notification acknowledgement. Contact your Roche Account Manager or contact Accu-Chek Customer Care at 1-800-628-3346 with questions.

    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