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

Remote Webmeeting Assessments

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  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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