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U.S. Department of Health and Human Services

Class 2 Device Recall Sanofi Aventis Diamigo iPhone App

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 Class 2 Recall
Sanofi Aventis Diamigo iPhone App
see related information
Date Posted December 22, 2012
Recall Status1 Open
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, New Jersey 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 2
PREMARKET APPROVAL: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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