PlainRecalls
FDA Devices Moderate Class II Terminated

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

Reported: February 21, 2018 Initiated: June 8, 2017 #Z-0625-2018

Product Description

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

Reason for Recall

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.

Details

Recalling Firm
Roche Diabetes Care, Inc.
Units Affected
67,040 unique users of version 2.1.0
Distribution
US Nationwide
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017. Recalled by Roche Diabetes Care, Inc.. Units affected: 67,040 unique users of version 2.1.0.
Why was this product recalled?
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0625-2018.