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U.S. Department of Health and Human Services

Class 2 Device Recall Dario Blood Glucose Monitoring System

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  Class 2 Device Recall Dario Blood Glucose Monitoring System see related information
Date Initiated by Firm August 29, 2019
Create Date October 31, 2019
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-0260-2020
Recall Event ID 83761
510(K)Number K150817  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Code Information Android App Software versions 4.3.0-4.3.2
Recalling Firm/
Manufacturer		 LABSTYLE INNOVATIONS
7, Derekh Menakhem Begin
Ramat Gan Israel
For Additional Information Contact Customer Service
800-8955921
Manufacturer 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 2		 Software change control
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.
Quantity in Commerce 126,271 (83,141 US; 43,130 OUS)
Distribution Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = LabStyle Innovations Ltd.
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