FDA-Device2018-02-21Class II
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Roche Diabetes Care, Inc.
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.
Sold states
US Nationwide
Affected count
67,040 unique users of version 2.1.0
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0625-2018Don't want to check this manually?
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