LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.