Z-1369-2015Class II

ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes...

Name: Z-1369-2015 ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes...
Creator: Roche Diabetes Care, Inc.
Published: 2014-10-30
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2014-10-30 / Terminated / root cause: software

FDA source

Roche Diabetes Care, Inc. began a recall of ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management on 2014-10-30. FDA classified it as Class II and gives the reason as "Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the...". 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-1369-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-30
Posted: 2015-04-02
Terminated: 2015-06-08
Recalling firm: Roche Diabetes Care, Inc.
Product: ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carb
Root cause tag: software
FDA root cause: Software design
Action: Urgent Field Safety Notices were sent to the customer and healthcare professional starting on 10/30/2014. The letter provided a description of the reason for the notification; and recommended that all users should update their app immediately.
Quantity in commerce: The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
Distribution: There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1369-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1369-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code JQP

K141929Class IIAccu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation / cleared 2015-03-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)