Recall Z-2406-2015 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Veridex, LLC
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
| Date | Aug 18, 2015 (initiated May 15, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex. |
| Quantity | 1560 kits |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 Veridex, LLC, Dec 21, 2010 |