Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of…

Recall date

May 20, 2022

Source

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

Recall number

Z-1345-2022

FDA classification

Class II

Brand / firm

Menarini Silicon Biosystems

Sold / distributed

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

Why it was recalled

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

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 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