BEUDAMED
    FDA Enforcement Class II Terminated

    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

    Recall: Z-0625-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0625-2018
    Event ID
    79001
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 21, 2018
    Initiation Date
    June 8, 2017
    Classification Date
    February 15, 2018
    Termination Date
    July 27, 2018
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

    Reason

    Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.

    Code Info

    Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0

    Distribution

    US Nationwide

    Quantity

    67,040 unique users of version 2.1.0