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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Product Detail

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

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.