Z-0586-2017Class II

Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

Name: Z-0586-2017 Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Creator: Roche Diabetes Care, Inc.
Published: 2016-09-14
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2016-09-14 / Terminated / root cause: software

FDA source

Roche Diabetes Care, Inc. began a recall of Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 on 2016-09-14. FDA classified it as Class II and gives the reason as "Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in 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-0586-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-14
Posted: 2016-11-16
Terminated: 2017-06-06
Recalling firm: Roche Diabetes Care, Inc.
Product: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Product code: NDC Calculator, Drug Dose
Reason for recall: Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Roche Diabetes Care, Inc., initiated a voluntary recall on September 14, 2016, of the version 1.2.0 of the Accu-Chek Connect app on iOS products (iPhone, iPad). The Prescription Activation Service (PAS) which allows the users to activate the bolus advice feature was placed on product hold immediately. This measure prevented any new bolus advice activations. An updated version (V 1.2.2) of the Accu-Chek Connect Diabetes Management App for iOS that contains the fix for the issue was released on August 29, 2016. Patients were instructed to: If you use the Accu-Chek Connect App on an IOS product (iPhone, iPad), please verify that you have installed the newest version of the app. Contact Accu-Chek Customer Care at 1-800-628-3346 if you have additional questions. HCPs were instructed to provide a copy of the UMDC to those patients to whom they have prescribed the Bolus Advisor on the Accu-Chek Connect App. No product returns are expected. Customers with questions may contact Accu-Chek Customer Care at 1-800-628-3346. For further questions please call (317) 521-4312,
Quantity in commerce: 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally
Distribution: US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin Foreign: None provided
Product codes and lots: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0586-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0586-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

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