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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Sanofi Aventis Diamigo i-Phone App		see related information
Date Posted December 22, 2012
Recall Number Z-0609-2013
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, New Jersey 08807
For Additional Information Contact Mr. WIlliam Inderlied
908-981-5276
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.
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.
 
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