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
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, 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.