ACCU-CHEK CONNECT recallZ-1099-2017 · Roche Diabetes Care, Inc. · initiated Dec 20, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1099-2017
- Status
- Terminated
- Initiated by the company
- Dec 20, 2016
- Posted by the FDA
- Jan 26, 2017
- Recalling firm
- Roche Diabetes Care, Inc.
- Quantity
- 27243
- Product code
- NDC
- FDA submissions
- K150910
- 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 description
Accu-Chek Connect Diabetes Management App
Code information (models, lots, serial numbers)
Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ACCU-CHEK CONNECT 07562462001Roche Diagnostics Operations, Inc. · Calculator, Drug Dose2 recalls2 reports
- ACCU-CHEK CONNECT 07250452001Roche Diagnostics Operations, Inc. · Calculator, Drug Dose1 recall4 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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