Skip to content
Recall Observatory FDA recall evidence

Device product

Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.

Z-0609-2013

September 21, 2012

Class II

Product summary

Firm
sanofi-aventis US, Inc.
Event
Event 63803
Status
Terminated
Classification
Class II
Quantity
1600 downloads (140 US; 1460 Foreign)
Official record key
device-enforcement:Z-0609-2013

Official wording

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.

Code information: n/a

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.