Z-0260-2020Class II

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

Name: Z-0260-2020 Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Creator: Labstyle Innovations
Published: 2019-08-29
License: https://open.fda.gov/license/

Labstyle Innovations, Ltd. / initiated 2019-08-29 / Terminated / root cause: software

FDA source

LABSTYLE INNOVATIONS began a recall of Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2 on 2019-08-29. FDA classified it as Class II and gives the reason as "The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0260-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-29
Posted: 2019-10-31
Terminated: 2020-05-05
Recalling firm: Labstyle Innovations, Ltd.
Product: Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: software
FDA 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 in commerce: 126,271 (83,141 US; 43,130 OUS)
Distribution: Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
Product codes and lots: Android App Software versions 4.3.0-4.3.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0260-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0260-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code NBW

K150817Class IIDario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. / cleared 2015-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)