Class 2 Device Recall Sanofi Aventis Diamigo iPhone App

• Date Initiated by Firm: September 21, 2012
• Date Posted: December 22, 2012
• Recall Status: Terminated on July 22, 2015
• Recall Number: Z-0609-2013
• Recall Event ID: 63803
• Product: Diamigo i-Phone App; ; The Diamigo app was intended for use as an educational tool in the management of diabetes.
• Code Information: n/a
• Recalling Firm/ Manufacturer: sanofi-aventis US, Inc.; Route 202-206; Bridgewater NJ 08807
• For Additional Information Contact: Mr. WIlliam Inderlied; 908-981-5276
• Manufacturer 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.
• FDA Determined Cause: No Marketing Application
• 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.
• Quantity in Commerce: 1600 downloads (140 US; 1460 Foreign)
• Distribution: Worldwide distribution.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.