Z-2753-2019Class II

Accu-Chek Connect Diabetes Management App

Name: Z-2753-2019 Accu-Chek Connect Diabetes Management App
Creator: Roche Diabetes Care, Inc.
Published: 2019-05-03
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2019-05-03 / Terminated / root cause: software

FDA source

Roche Diabetes Care, Inc. began a recall of Accu-Chek Connect Diabetes Management App on 2019-05-03. FDA classified it as Class II and gives the reason as "Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2753-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Posted: 2019-09-26
Terminated: 2020-10-30
Recalling firm: Roche Diabetes Care, Inc.
Product: Accu-Chek Connect Diabetes Management App
Product code: NDC Calculator, Drug Dose
Reason for recall: Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Connect App version 2.1.6.3 when used with Android OS 8.0 and above.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2753-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2753-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-26

Product code NDC

K150910Class IIACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. / cleared 2015-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)