FDA Medical Device Recalls (openFDA)
Roche Diabetes Care, Inc.: ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
- Recall number
- Z-1369-2015
- Recalling firm
- Roche Diabetes Care, Inc.
- Product
- ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
- Status
- Terminated
- Initiated
- 2014-10-30
- Posted
- 2015-04-02
- Terminated
- 2015-06-08
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- N/A
- 510(k) numbers
- ["K141929"]
- PMA numbers
- not on file
- Product code
- JQP
- 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