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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Connect App

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  Class 2 Device Recall AccuChek Connect App see related information
Date Initiated by Firm May 03, 2019
Create Date September 26, 2019
Recall Status1 Open3, Classified
Recall Number Z-2753-2019
Recall Event ID 83566
510(K)Number K150910  
Product Classification Calculator, drug dose - Product Code NDC
Product Accu-Chek Connect Diabetes Management App
Code Information Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
Recalling Firm/
Manufacturer
Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Customer Care Software Support
800-628-3346
Manufacturer Reason
for Recall
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
FDA Determined
Cause 2
Software in the Use Environment
Action On 5/2/19, the firm notified affiliates of the issue via a Quality Notice. On 5/16/19, the firm issued an updated Quality Notice stating that a new version of the software, 2.1.7.2 would soon become available which would resolve the data transfer issues. Call centers were also provided with a workaround for customers who called in reporting an issue with transferring results. On 5/24/19, version 2.1.7.2 of the Connect App was released for Android on the Google Play store. This version of the app corrects the data transfer issue. At this time, users were notified via the "What's New" section of Google Play. These users were informed that the new version addresses issues with wireless data transfers from blood glucose meters. Customers with questions regarding this event should call the ACCU-CHEK Customer Care Software support line at 1-800-628-3346.
Distribution Nationwide and worldwide usage of the Connect App.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NDC and Original Applicant = ROCHE DIABETES CARE INC.
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