Menarini Silicon Biosystems: Medical Device Recall in 2022 - (Recall #: Z-1345-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

Product Classification:

Class II

Date Initiated: May 20, 2022

Date Posted: July 13, 2022

Recall Number: Z-1345-2022

Event ID: 90417

Reason for Recall:

High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

Status: Ongoing

Product Quantity: 484 units

Code Information:

UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022

Distribution Pattern:

CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,

Voluntary or Mandated:

Voluntary: Firm initiated