cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-ana...
FDA Device Recall #Z-0110-2017 — Class II — July 15, 2016
Recall Summary
| Recall Number | Z-0110-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 15, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diagnostics Operations, Inc. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 9014 in total |
Product Description
cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).
Reason for Recall
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Not applicable
Other Recalls from Roche Diagnostics Operations, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1476-2026 | Class II | cobas pro integrated solutions with cobas c 503... | Jan 20, 2026 |
| Z-1009-2026 | Class II | The Elecsys Anti-TSHR immunoassay is a three-st... | Nov 21, 2025 |
| Z-0489-2025 | Class II | cobas HCYS, Homocysteine Enzymatic Assay, Mater... | Oct 17, 2024 |
| Z-3187-2024 | Class II | Creatine Kinase (CK) used on cobas c 311/501/50... | Aug 15, 2024 |
| Z-0352-2024 | Class II | Tina-quant D-Dimer Test System, Fibrinogen/Fibr... | Oct 3, 2023 |
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.