Recall Z-1530-2018 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Menarini Silicon Biosystems
CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
| Date | Apr 4, 2018 |
| Status | Terminated |
| Reason | Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results. |
| Root cause | Process design |
| Action | Menarini silicon biosystems sent an Urgent Medical Device Correction Notification dated April 3, 2018. Required Actions. " Please dispose of any affected product in your current inventory . " Report any previous occurrence of unusually high number of total images I unassigned events in patient samples to Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than April 20,2018. For further question, please call (215) 830-0777. |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy |
| 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 |