CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOP...
FDA Device Recall #Z-1950-2013 - Class II, December 28, 2012
Recall Summary
| Recall Number | Z-1950-2013 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 28, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Veridex, LLC |
| Location | Raritan, NJ |
| Product Type | Devices |
| Quantity | US: 70 Units; Ex-US 76 Units |
Product Description
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.
Reason for Recall
Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
Lot / Code Information
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555).
Other Recalls from Veridex, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2406-2015 | Class II | Cell Search Circulating Tumor Kit. Intended for... | May 15, 2015 |
| 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 |
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.