Sanofi-Aventis Recalls Diamigo Diabetes App Due to Unintended Global Access
Sanofi-Aventis is recalling the Diamigo iPhone app because it was inadvertently made available globally instead of being restricted to Brazil.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a distribution error (unintended global access) rather than a direct physical or chemical safety defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sanofi-Aventis US, Inc. is recalling the Diamigo iPhone app, a software application intended for use as an educational tool in the management of diabetes. The recall is due to an error in the app's distribution through the iPhone Global Store, which inadvertently allowed global access to the application. The original intent was to restrict access to Brazil only.
The recall affects 1,600 downloads, comprising 140 in the United States and 1,460 in foreign countries. The distribution pattern is listed as worldwide. No specific lot numbers or dates are provided in the source text.
Consumers who have downloaded the app should be aware that it was not intended for use outside of Brazil. The source text does not specify further consumer actions or report any illnesses or injuries associated with the use of the application.
The recalled product
- Product
- 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.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- n/a
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · sanofi-aventis US, Inc.
See all →- ModerateSanofi-aventis Recalls Eloxatin Injection Due to Manufacturing Issues
FDA (Drugs) · 2012-07-11
- ModerateSanofi Recalls Eloxatin Injection Due to Manufacturing Practice Deviations
FDA (Drugs) · 2012-07-11
Same hazard · unintended distribution
See all →- ModerateSmall DKS Disposable Kerrison System Inadvertently Distributed
FDA (Devices) · 2024-12-18
Similar recalls
- HighMiniMed Go App Recalled Due to Missed Insulin Alerts
FDA (Devices) · 2026-07-29
- HighRoche Recalls Accu-Chek Connect App Due to Inaccurate Bolus Advice
FDA (Devices) · 2015-04-08
- HighInPen app recalled over software errors affecting insulin dose reminders
FDA (Devices) · 2025-09-10
- SevereSanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
FDA (Drugs) · 2019-12-11
- SevereRoche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors
FDA (Devices) · 2017-02-01
- SevereRoche Recalls Accu-Chek Connect App Due to Bolus Advisor Error
FDA (Devices) · 2017-05-10