sanofi-aventis US, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0609-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 21, 2012

Date Posted: January 2, 2013

Recall Number: Z-0609-2013

Event ID: 63803

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.

Status: Terminated

Product Quantity: 1600 downloads (140 US; 1460 Foreign)

Code Information:

n/a

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated