FDA Medical Device Recalls (openFDA)
sanofi-aventis US, Inc.: Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
- Recall number
- Z-0609-2013
- Recalling firm
- sanofi-aventis US, Inc.
- Product
- Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
- Status
- Terminated
- Initiated
- 2012-09-21
- Posted
- 2012-12-22
- Terminated
- 2015-07-22
- 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.
- 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
- 1600 downloads (140 US; 1460 Foreign)
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- n/a
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2222017
- Firm city
- Bridgewater
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28