Recall Z-1949-2013 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Veridex, LLC
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & 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
| Date | Aug 10, 2013 (initiated Dec 28, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Veridex sent an Important Product Correction Notification letter dated December 28, 2012, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311. |
| Quantity | US: 82 Units; Ex-US 78 Units. |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain. |
| FDA record | Open on fda.gov |