Recall Z-0260-2020
Labstyle Innovations · initiated August 29, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Codes / lots: Android App Software versions 4.3.0-4.3.2
Reason for recall
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
FDA-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-0260-2020
- Initiated
- August 29, 2019
- Terminated
- May 5, 2020
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 126,271 (83,141 US; 43,130 OUS)
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
- Recalling firm
- Labstyle Innovations, Ramat Gan