Z-0625-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- June 8, 2017
- Termination Date
- July 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,040 unique users of version 2.1.0
Product Description
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Reason for Recall
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
Distribution Pattern
US Nationwide
Code Information
Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0