Diamigo i-Phone App The Diamigo app was intended for use as an… — Class II medical device recall Z-0609-2013
Terminated recall by sanofi-aventis US, Inc., reported 2013-01-02. Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed glo
| Recall number | Z-0609-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | sanofi-aventis US, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2012-09-21 |
| Classified | 2012-12-21 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2015-07-22 |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0609-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.