Company: Roche Diabetes Care
Date of Enforcement Report 11/23/2016
Class lI:
PRODUCT
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Recall Number Z-0586-2017
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.
RECALLING FIRM/MANUFACTURER
Roche Diabetes Care., Indianapolis, IN on 11/16/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
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
DISTRIBUTION
Nationwide
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