Z-0609-2013 Class II Terminated
FDA device recall Z-0609-2013 was initiated by sanofi-aventis US, Inc. on September 21, 2012 and is designated Class II. Reason for recall: Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to… The recall status is terminated (terminated July 22, 2015). Affected quantity: 1600 downloads (140 US; 1460 Foreign).
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2013
- Initiation Date
- September 21, 2012
- Termination Date
- July 22, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1600 downloads (140 US; 1460 Foreign)
Product Description
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Reason for Recall
Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.
Distribution Pattern
Worldwide distribution.
Code Information
n/a