23
Nov
2016

Accu-Chek Connect Diabetes Management App Cl II

0

Company: Roche Diabetes Care
Date of Enforcement Report 11/23/2016
Class lI:

PRODUCT

Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Recall Number Z-0586-2017

REASON
Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.

RECALLING FIRM/MANUFACTURER
Roche Diabetes Care., Indianapolis, IN on 11/16/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally

DISTRIBUTION
Nationwide

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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.

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