PRA number
2019/17815
Published date
Product description
Dario Blood Glucose Tracker App
Android App Versions 4.3.0-4.3.2
ATRG 229859
(IBD Medical - Software IVDs)
An in vitro diagnostic medical device (IVD)
Android App Versions 4.3.0-4.3.2
ATRG 229859
(IBD Medical - Software IVDs)
An in vitro diagnostic medical device (IVD)
Reasons the product is recalled
Potential issue with Android App versions of Dario Blood Glucose Tracker (4.3.0-4.3.2), regarding duplicate logging of a blood glucose level reading. The issue may cause blood glucose level readings that are transferred from the measurement screen to the 'Logbook' being replaced by an older blood glucose measurement and being displayed as a duplicate reading.
The hazards to consumers
If inaccurate blood glucose level reading from the 'Data Entry' or 'Logbook' screens are used to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions, which can lead to serious health complications.
What consumers should do
Update the latest Dario - Blood Glucose Tracker Android App version as follows:
Open the Google Play store
Search for 'Dario Blood Glucose Tracker' App
Press the 'Uninstall' button
Press 'OK' to confirm the question "Do you want to uninstall this app?"
Once completed, press 'Install' and verify 4.3.3 version (or above) has been installed by pressing the 'About this App' link.
For further information, contact IBD Medical on 02 8398 7520
Open the Google Play store
Search for 'Dario Blood Glucose Tracker' App
Press the 'Uninstall' button
Press 'OK' to confirm the question "Do you want to uninstall this app?"
Once completed, press 'Install' and verify 4.3.3 version (or above) has been installed by pressing the 'About this App' link.
For further information, contact IBD Medical on 02 8398 7520
Supplier
Traders who sold this product
Google Play Store
Where the product was sold
Nationally
Online
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.