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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

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