| Class 2 Device Recall Dario Blood Glucose Monitoring System |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NBW
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