Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Connect App

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AccuChek Connect Appsee related information
Date Initiated by FirmMay 03, 2019
Create DateSeptember 26, 2019
Recall Status1 Terminated 3 on October 30, 2020
Recall NumberZ-2753-2019
Recall Event ID 83566
510(K)NumberK150910 
Product Classification Calculator, drug dose - Product Code NDC
ProductAccu-Chek Connect Diabetes Management App
Code Information Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
FEI Number 3011393376
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactCustomer 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
ActionOn 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.
DistributionNationwide and worldwide usage of the Connect App.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = NDC
-
-