Veridex, LLC: Medical Device Recall in 2015 - (Recall #: Z-2406-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 15, 2015

Date Posted: August 26, 2015

Recall Number: Z-2406-2015

Event ID: 71673

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.

Status: Terminated

Product Quantity: 1560 kits

Code Information:

Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated