Events

Recall of Sanofi Aventis Diamigo iPhone App

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by sanofi-aventis US, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63803
  • Event Risk Class
    Class 2
  • Event Number
    Z-0609-2013
  • Event Initiated Date
    2012-09-21
  • Event Date Posted
    2012-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114792
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • 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.
  • 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.

Device

Sanofi Aventis Diamigo iPhone App
  • Model / Serial
  • Distribution
    Worldwide distribution.
  • Product Description
    Diamigo i-Phone App || The Diamigo app was intended for use as an educational tool in the management of diabetes.
  • Manufacturer
    sanofi-aventis US, Inc.

Manufacturer

sanofi-aventis US, Inc.
  • Manufacturer Address
    sanofi-aventis US, Inc., Route 202-206, Bridgewater NJ 08807
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA