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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013
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Event Detail

Event ID 63803
Product Type Devices
Status Ongoing
Recalling Firm sanofi-aventis US, Inc.
City Bridgewater
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-21
Initial Firm Notification of
Consignee or Public		 Other
Distribution Pattern Worldwide distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. n/a Class II 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. 1600 downloads (140 US; 1460 Foreign) Z-0609-2013
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