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
___________________________________
