Z-0260-2020 Class II Terminated
FDA device recall Z-0260-2020 was initiated by LABSTYLE INNOVATIONS on August 29, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 5, 2020). Affected quantity: 126,271 (83,141 US; 43,130 OUS).
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