BEUDAMED
    FDA Recall Terminated

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    Recall: Z-0260-2020 · Initiated August 29, 2019

    Recall

    Recall Number
    Z-0260-2020
    Event Number
    83761
    Firm
    LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel
    FEI Number
    3010606081
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    August 29, 2019
    Terminated
    May 5, 2020

    Description

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    Reason

    The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

    Action

    The firm released Android App version 4.3.3 on August 29, 2019. Users were informed about the issue via push notification on 8/30/19, asking to update to the new version. An additional push notification was sent on 8/31/19, along with a Field Safety Notice letter sent to their "inbox". On 9/9/19, remaining potential relevant users received a third notification in which they were asked to upgrade their version through in-app and push notifications. Customers were instructed to do the following: Please update the latest Dario - Blood Glucose Tracker Android App version as follows o Open the Google Play store o Search for Dario Blood Glucose Tracker App o Press Uninstall button o Press OK to confirm the question "Do you want to uninstall this app?" o Once completed, press Install and verify you installed 4.3.3 version (or above) by pressing the "About this App" link. Customers with questions should contact the firm's Customer Service Center at 1-800-895-5921, Monday Friday, 9AM 5PM Eastern.

    Distribution

    Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.

    Quantity

    126,271 (83,141 US; 43,130 OUS)