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.
- Company
- Menarini Silicon Biosystems
- Recall Initiated
- April 4, 2018
- Terminated
- April 9, 2019
- Recall Number
- Z-1530-2018
- Firm Location
- Huntingdon Valley, PA
Reason for Recall
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.
Distribution
Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
Lot / Code Info
UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
Root Cause
Process design
Action Taken
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.