Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) ...
FDA Device Recall #Z-2406-2015 — Class II — May 15, 2015
Recall Summary
| Recall Number | Z-2406-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 15, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Veridex, LLC |
| Location | Raritan, NJ |
| Product Type | Devices |
| Quantity | 1560 kits |
Product Description
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Reason for Recall
Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12
Other Recalls from Veridex, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1195-2014 | Class II | CELLTRACKS ANALYZER II¿ (Product Code 9555) ... | Jan 8, 2014 |
| Z-1949-2013 | Class II | CELLTRACKS AUTOPREP System (Software Version 2.... | Dec 28, 2012 |
| Z-1950-2013 | Class II | CELLTRACKS ANALYZER II (Software Version 2.5.1 ... | Dec 28, 2012 |
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.