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Roche Diabetes Care, Inc. recalls Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 0725
Recalled February 21, 2018 · FDA recall Z-0625-2018 · Roche Diabetes Care
Hazard
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. · FDA Class II
Units
67,040 unique users of version 2.1.0
Sold at
US Nationwide
Description
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.
Product
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Manufacturer(s)
Roche Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →