FDA Medical Device Recalls (openFDA)
LABSTYLE INNOVATIONS: Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
- Recall number
- Z-0260-2020
- Recalling firm
- LABSTYLE INNOVATIONS
- Product
- Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
- Status
- Terminated
- Initiated
- 2019-08-29
- Posted
- not on file
- Terminated
- 2020-05-05
- 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.
- Root cause
- 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
- 126,271 (83,141 US; 43,130 OUS)
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
- Lot, serial or model codes
- Android App Software versions 4.3.0-4.3.2
- 510(k) numbers
- ["K150817"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3010606081
- Firm city
- Ramat Gan
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28