Cl ll igo i-Phone App

Company: sanofi-aventis US, Inc..
Date of Enforcement Report 1/2/2013
Class ll:

PRODUCT

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

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/MANUFACTURER
sanofi-aventis US, Inc., Bridgewater, NJ 9/21/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1600 downloads (140 US; 1460 Foreign)

DISTRIBUTION
Worldwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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