Company: sanofi-aventis US, Inc..
Date of Enforcement Report 1/2/2013
Class ll:

PRODUCT

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

REASON
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

RECALLING FIRM/MANUFACTURER
sanofi-aventis US, Inc., Bridgewater, NJ 9/21/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1600 downloads (140 US; 1460 Foreign)

DISTRIBUTION
Worldwide

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