Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalo...
FDA Device Recall #Z-0997-2020 — Class II — December 11, 2019
Recall Summary
| Recall Number | Z-0997-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 11, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diabetes Care, Inc. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 82,332 vials |
Product Description
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Reason for Recall
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Distribution Pattern
Nationwide: Foreign: Austalia, India
Lot / Code Information
Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1
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-2353-2021 | Class II | Accu-Chek SmartView Test Strip, Blood Glucose M... | Jul 28, 2021 |
| Z-2351-2021 | Class II | Accu-Chek Aviva Plus Test Strip, Blood Glucose ... | Jul 28, 2021 |
| Z-2354-2021 | Class II | Accu-Chek Inform II Test Strip, Whole Blood Glu... | 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.