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Terminated

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

FDA Recall Z-0609-2013 · Posted 2012-12-22

Recalling Firmsanofi-aventis US, Inc.
Recall StatusTerminated
Date Initiated2012-09-21
Date Terminated2015-07-22
Product Quantity1600 downloads (140 US; 1460 Foreign)

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.

Firm Action

Apple sent a message ("push notification") on September 21, 2012 to its customers. The message describes the product, problem and actions to be taken. The customers were instructed not to use the app to calculate insulin does and should delete if from their device(s). If you have additional questions about the app or this message, contact Sanofi's offices in your country. If you are in the U.S. contact Sanofi US Medical Information at 1-800-633-1610, for Brazil please contact 0800 703 0080.

Root Cause

No Marketing Application

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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