Z-1099-2017Class II

Accu-Chek Connect Diabetes Management App

Name: Z-1099-2017 Accu-Chek Connect Diabetes Management App
Creator: Roche Diabetes Care, Inc.
Published: 2016-12-20
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2016-12-20 / Terminated / root cause: software

FDA source

Roche Diabetes Care, Inc. began a recall of Accu-Chek Connect Diabetes Management App on 2016-12-20. FDA classified it as Class II and gives the reason as "iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and...". 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-1099-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-20
Posted: 2017-01-26
Terminated: 2017-09-05
Recalling firm: Roche Diabetes Care, Inc.
Product: Accu-Chek Connect Diabetes Management App
Product code: NDC Calculator, Drug Dose
Reason for recall: iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
Root cause tag: software
FDA root cause: Software design
Action: Customers were notified via Google Play Store or the Apple App Store that an update to the Accu-Chek Connect App was available on December 20, 2016.. The description of the new version available in the app stores indicated that the new version resolved issues with the Bolus Advisor. It also includes direction to the Accu-Chek website. On December 21, 2016, information regarding the issues corrected with the new version was placed on the website. The information on the website was replaced on January 10, 2017, with the patient version of the Urgent Medical Device Correction (UMDC) which was sent on January 10, 2017, to US HCPs who have received prescription pads that would allow them to prescribe the bolus advice activation. If you have additional concerns, please contact the Accu-Chek Customer Service Center at 1- 800-858-8072. All other versions of the app as well as other Accu-Chek products using the bolus advice feature are not affected by this issue.
Quantity in commerce: 27243
Distribution: Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.
Product codes and lots: Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26

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)