Recall – Diabetes management app communication error

Company: Roche Diabetes Care, Inc.
Date of Enforcement Report: 10/2/2019
Class II

PRODUCT

Accu-Chek Connect Diabetes Management App

  • Recall Number: Z-2753-2019

REASON

Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.

RECALLING FIRM/MANUFACTURER

Roche Diabetes Care, Inc. on 5/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

 

DISTRIBUTION

US Nationwide and International

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.