Roche Diabetes Care, Inc. recalls Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

Recall date

September 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0586-2017

FDA classification

Class II

Brand / firm

Roche Diabetes Care, Inc.

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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