Menarini Silicon Biosystems

2 recalls •

• Categories: Infusion Pumps

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

Class I - Dangerous

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

May 20, 2022 Infusion Pumps View Details →

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.

Class I - Dangerous

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.

Apr 4, 2018 Infusion Pumps Nationwide View Details →