Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Reported: November 23, 2016 Initiated: September 14, 2016 #Z-0586-2017
Product Description
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Reason for Recall
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.
Details
- Recalling Firm
- Roche Diabetes Care, Inc.
- Units Affected
- 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
- 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
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016. Recalled by Roche Diabetes Care, Inc.. Units affected: 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.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0586-2017.
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