FDA Medical Device Recalls (openFDA)
Roche Diabetes Care, Inc.: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
- Recall number
- Z-0586-2017
- Recalling firm
- Roche Diabetes Care, Inc.
- Product
- Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
- Status
- Terminated
- Initiated
- 2016-09-14
- Posted
- 2016-11-16
- Terminated
- 2017-06-06
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000
- 510(k) numbers
- ["K150910"]
- PMA numbers
- not on file
- Product code
- NDC
- Firm FEI
- 3011393376
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28