Date Initiated by Firm |
May 03, 2019 |
Create Date |
September 26, 2019 |
Recall Status1 |
Terminated 3 on October 30, 2020 |
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
|
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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) Database |
510(K)s with Product Code = NDC and Original Applicant = ROCHE DIABETES CARE INC.
|