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

Is my product affected?

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

• UPC 07562462001
• UPC 00365702700000

Check against the official notice below — it lists the full affected range.

What happened

Roche Diabetes Care, Inc. voluntarily recalled version 1.2.0 of the Accu-Chek Connect Diabetes Management App for iOS, released on July 11, 2016. The app contained a programming error in the Bolus Advisor feature that could cause incorrect insulin bolus recommendations. The affected version was downloaded 7,909 times in the US across multiple states and 8,775 times internationally.

The recall source does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. 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 Quantity: 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 Lot/code info: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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