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. |
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