Home / Recalls / Menarini Silicon Biosystems / Z-1345-2022

Z-1345-2022 Class II Ongoing

Recalled by Menarini Silicon Biosystems — Huntingdon Valley, PA

Recall Details

Product Type: Devices
Report Date: July 13, 2022
Initiation Date: May 20, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 484 units

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

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

Distribution Pattern

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

Code Information

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