Z-1899-2017Class II

Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android

Name: Z-1899-2017 Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Creator: Roche Diabetes Care, Inc.
Published: 2017-03-14
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2017-03-14 / Terminated / root cause: software

FDA source

Roche Diabetes Care, Inc. began a recall of Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download... on 2017-03-14. FDA classified it as Class II and gives the reason as "A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery". 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-1899-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-14
Posted: 2017-05-01
Terminated: 2018-01-16
Recalling firm: Roche Diabetes Care, Inc.
Product: Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
Product code: NDC Calculator, Drug Dose
Reason for recall: A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
Root cause tag: software
FDA root cause: Software design
Action: Roche Diabetes Care, Inc. discovered a software issue in the Accu-Chek Connect app versions 2.0.0, 2.0.1, and 2.1.0 that can result in incorrect bolus recommendations. This software bug may result in errors in the active insulin calculation, creating the potential for a false high insulin bolus recommendation. An insulin bolus delivered based on potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Customer notices were distributed via mail on 03/30/2017, and the firm's website was also updated with recall information on that day. Customers were instructed to do the following: discontinue use of the bolus advisor feature in app versions 2.0.0, 2.0.1, and 2.1.0 (iOS & Android) until the corrected version is available. Provide patients with a copy of the enclosed Urgent Medical Device Correction 17-001. Complete the enclosed faxback form and fax it to Roche Diabetes Care, Inc., at 1-888-912-8456. If you have questions about the information in this notification, please contact Accu-Chek Customer Care by visiting accu-chek.com or by calling 1-800-688-4578. The corrected version of the app is expected to be available on or about April 13, 2017. New patients will be able to begin using the bolus advisor feature once the corrected version is available. Please advise your patients to visit accu-chek.com for updates regarding the availability of the corrected version of the app.
Quantity in commerce: 64,324
Distribution: US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
Product codes and lots: Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1899-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1899-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-01

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)