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Recall Observatory FDA recall evidence

Device product

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

Z-0586-2017

September 14, 2016

Class II

Product summary

Firm
Roche Diabetes Care, Inc.
Event
Event 75241
Status
Terminated
Classification
Class II
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
Official record key
device-enforcement:Z-0586-2017

Official wording

Reason: 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.

Code information: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000

Distribution pattern: 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software containing a programming error (bug