Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
This recall has been terminated (originally issued December 22, 2012).
- Recall Initiated
- September 21, 2012
- Posted
- December 22, 2012
- Terminated
- July 22, 2015
- Recall Number
- Z-0609-2013
- Quantity
- 1600 downloads (140 US; 1460 Foreign)
- Firm Location
- Bridgewater, NJ
- Official Source
- View on FDA website ↗
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
Worldwide distribution.
Root Cause
No Marketing Application
Action Taken
Apple sent a message ("push notification") on September 21, 2012 to its customers. The message describes the product, problem and actions to be taken. The customers were instructed not to use the app to calculate insulin does and should delete if from their device(s). If you have additional questions about the app or this message, contact Sanofi's offices in your country. If you are in the U.S. contact Sanofi US Medical Information at 1-800-633-1610, for Brazil please contact 0800 703 0080.