BEUDAMED
    FDA Enforcement Class II Terminated

    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    Recall: Z-0586-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0586-2017
    Event ID
    75241
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 23, 2016
    Initiation Date
    September 14, 2016
    Classification Date
    November 16, 2016
    Termination Date
    June 6, 2017
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    Reason

    Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.

    Code Info

    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000

    Distribution

    US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin Foreign: None provided

    Quantity

    7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally