Home / Recalls / Veridex, LLC / Z-2406-2015

Z-2406-2015 Class II Terminated

Recalled by Veridex, LLC — Raritan, NJ

Recall Details

Product Type
Devices
Report Date
August 26, 2015
Initiation Date
May 15, 2015
Termination Date
March 30, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1560 kits

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.

Distribution Pattern

Nationwide Distribution.

Code Information

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

Other recalls by Veridex, LLC

  • Z-1195-2014 Class II — CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS (January 8, 2014)
  • Z-1949-2013 Class II — CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: (December 28, 2012)
  • Z-1950-2013 Class II — CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The (December 28, 2012)