FDA-Device2016-11-23Class II

Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

Roche Diabetes Care, Inc.

Hazard

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.

Sold states

US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin Foreign: None provided

Affected count

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

Manufactured in

9115 Hague Rd, N/A, Indianapolis, IN, United States

Products

Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0586-2017

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