Feb

2018

Cl II Accu-Chek Connect Diabetes Management App

Company:Roche Diabetes Care, Inc.
Date of Enforcement Report 2/21/2018
Class lI:

PRODUCT

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Recall Number Z-0625-2018

REASON
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice. .

RECALLING FIRM/MANUFACTURER
Roche Diabetes Care, Inc., Indianapolis, IN on 6/8/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
67,040 unique users of version 2.1.0

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

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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Cl II Accu-Chek Connect Diabetes Management App

Amy Sellers

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