Veridex, LLC recalls Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin i…

Recall date

May 15, 2015

Source

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

Recall number

Z-2406-2015

FDA classification

Class II

Brand / firm

Veridex, LLC

Sold / distributed

Nationwide Distribution.

Why it was recalled

Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.

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

What was recalled

Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.