LABSTYLE INNOVATIONS: Medical Device Recall in 2019 - (Recall #: Z-0260-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 29, 2019

Date Posted: November 6, 2019

Recall Number: Z-0260-2020

Event ID: 83761

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.

Status: Terminated

Product Quantity: 126,271 (83,141 US; 43,130 OUS)

Code Information:

Android App Software versions 4.3.0-4.3.2

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated