Company:Roche Diabetes Care, Inc.
Date of Enforcement Report 2/21/2018
Class lI:
PRODUCT
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Recall Number Z-0625-2018
REASON
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. .
RECALLING FIRM/MANUFACTURER
Roche Diabetes Care, Inc., Indianapolis, IN on 6/8/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
67,040 unique users of version 2.1.0
DISTRIBUTION
Nationwide
___________________________________
