Z-0609-2013Class II

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

Name: Z-0609-2013 Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes
Creator: sanofi-aventis US, Inc.
Published: 2012-09-21
License: https://open.fda.gov/license/

Sanofi Aventis U.S., LLC / initiated 2012-09-21 / Terminated / root cause: software

FDA source

sanofi-aventis US, Inc. began a recall of Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes on 2012-09-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0609-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-21
Posted: 2012-12-22
Terminated: 2015-07-22
Recalling firm: Sanofi Aventis U.S., LLC
Product: Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
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.
Root cause tag: software
FDA root cause: No Marketing Application
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.
Quantity in commerce: 1600 downloads (140 US; 1460 Foreign)
Distribution: Worldwide distribution.
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0609-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0609-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-21

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)