cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, s...
FDA Device Recall #Z-2136-2018 — Class II — April 3, 2018
Recall Summary
| Recall Number | Z-2136-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 3, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diagnostics Corporation |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 35 |
Product Description
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Reason for Recall
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
Distribution Pattern
US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
Lot / Code Information
Serial numbers: 1744-08 1744-09 1744-10 1758-08 1606-09 1752-05 1752-06 1630-08 1738-01 1744-07 1758-09 1759-04 1758-06 1758-07 1743-09 1743-10 1752-04 1759-05 17C5-06 17C5-07 1615-08 1612-10 17C5-09 1744-05 1744-06 1743-07 1743-08 1744-03 1744-04 1759-06 17C5-05 17C5-08 17C5-10 17C6-01 17C6-02
Other Recalls from Roche Diagnostics Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1979-2019 | Class II | The Tina-quant lgA Gen.2 is an immunoturbidimet... | Jun 3, 2019 |
| Z-1928-2019 | Class III | cobas p 701 post-analytical units, Part Number ... | Apr 4, 2019 |
| Z-1927-2019 | Class III | cobas p 501 post-analytical units, Part Number ... | Apr 4, 2019 |
| Z-1194-2019 | Class II | Albumin BCP Product Usage: ALBP is an in v... | Mar 18, 2019 |
| Z-1249-2019 | Class II | cobas e 801 immunoassay analyzer | Mar 15, 2019 |
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.