Menarini Silicon Biosystems: Medical Device Recall in 2018 - (Recall #: Z-1530-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 4, 2018

Date Posted: May 2, 2018

Recall Number: Z-1530-2018

Event ID: 79872

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.

Status: Terminated

Product Quantity: N/A

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated