Home / Recalls / LABSTYLE INNOVATIONS / Z-0260-2020

Z-0260-2020 Class II Terminated

Recalled by LABSTYLE INNOVATIONS — Ramat Gan

Recall Details

Product Type
Devices
Report Date
November 6, 2019
Initiation Date
August 29, 2019
Termination Date
May 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
126,271 (83,141 US; 43,130 OUS)

Product Description

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android 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.

Distribution Pattern

Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.

Code Information

Android App Software versions 4.3.0-4.3.2