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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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