FDA-Device2013-01-02Class II
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
sanofi-aventis US, Inc.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
1600 downloads (140 US; 1460 Foreign)
Manufactured in
Route 202-206, N/A, Bridgewater, NJ, United States
Products
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0609-2013Don't want to check this manually?
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