Z-1369-2015 Class II Terminated
FDA device recall Z-1369-2015 was initiated by Roche Diabetes Care, Inc. on Oct 30, 2014 and is designated Class II. Reason for recall: Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough… The recall status is terminated (terminated Jun 8, 2015). Affected quantity: The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus…
Recall Details
- Product Type
- Devices
- Report Date
- Apr 8, 2015
- Initiation Date
- Oct 30, 2014
- Termination Date
- Jun 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
Product Description
Reason for Recall
Distribution Pattern
There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1369-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026