Menarini Silicon Biosystems recalls CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended…

Recall date

April 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1530-2018

FDA classification

Class II

Brand / firm

Menarini Silicon Biosystems

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.