Recall Z-0609-2013— sanofi-aventis US, Inc.
Class II · Terminated
Class II FDA medical device recall by sanofi-aventis US, Inc., initiated 2012-09-21, terminated 2015-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.. 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..
- Recalling firm
- sanofi-aventis US, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-21
- Terminated
- 2015-07-22
- Firm location
- Bridgewater, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.