Drug recall
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
FDA recall event 63803 · Class II · sanofi-aventis US, Inc.
Key facts
| Event ID | 63803 |
|---|---|
| Recall numbers | Z-0609-2013 |
| Recalling firm | sanofi-aventis US, Inc. |
| Product type | Devices |
| Products | Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 21, 2012 |
| Report date | Jan 2, 2013 |
| Termination date | Jul 22, 2015 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 2222017 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: