Device product
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Z-0260-2020
Product summary
- Event
- Event 83761
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126,271 (83,141 US; 43,130 OUS)
- Official record key
device-enforcement:Z-0260-2020
Official wording
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.
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.
Derived failure modes
-
Unknown
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.