Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 0036...
FDA Device Recall #Z-0197-2018 — Class II — June 8, 2017
Recall Summary
| Recall Number | Z-0197-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 8, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diabetes Care, Inc. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 1,134 bolus advisor features used |
Product Description
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
Reason for Recall
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
Distribution Pattern
Worldwide Distribution - US (Nationwide) and Canada
Lot / Code Information
Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android.
Other Recalls from Roche Diabetes Care, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2174-2024 | Class II | Accu-Chek Guide (SC) Kit -Intended to quantitat... | May 13, 2024 |
| Z-1008-2022 | Class II | RocheDiabetes Care Platform Software version 2.... | Mar 9, 2022 |
| Z-2351-2021 | Class II | Accu-Chek Aviva Plus Test Strip, Blood Glucose ... | Jul 28, 2021 |
| Z-2353-2021 | Class II | Accu-Chek SmartView Test Strip, Blood Glucose M... | Jul 28, 2021 |
| Z-2352-2021 | Class II | Accu-Chek Performa Test Strip, Blood Glucose Mo... | Jul 28, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.