Home / Recalls / Menarini Silicon Biosystems / Z-1530-2018

Z-1530-2018 Class II Terminated

Recalled by Menarini Silicon Biosystems — Huntingdon Valley, PA

Recall Details

Product Type: Devices
Report Date: May 2, 2018
Initiation Date: April 4, 2018
Termination Date: April 9, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

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.

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 Pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy

Code Information

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)