FDA Recall Terminated

Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.

Recall: Z-0609-2013 · Initiated September 21, 2012

Recall

Recall Number
Z-0609-2013
Event Number
63803
Firm
sanofi-aventis US, Inc. Route 202-206
FEI Number
2222017
Status
Terminated
Root Cause
No Marketing Application
Initiated
September 21, 2012
Posted
December 22, 2012
Terminated
July 22, 2015
Address
Bridgewater, NJ, 08807

Description

Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.

Reason

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.

Action

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.

Distribution

Worldwide distribution.

Quantity

1600 downloads (140 US; 1460 Foreign)