Recall Z-2406-2015— Veridex, LLC

Name: FDA recall Z-2406-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-15

Class II · Terminated

Class II FDA medical device recall by Veridex, LLC, initiated 2015-05-15, terminated 2016-03-30. It names one FDA 510(k) clearance: K103502. Product: Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.. Reason: 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..

Recalling firm: Veridex, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Terminated: 2016-03-30
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001Veridex, LLC·cleared 2010-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.