Celltracks Autoprep System

• 2 recalls, same reason

  • Terminated Z-1949-2013 FDA Class II ·initiated 28 Dec 2012
  • Terminated Z-1950-2013 FDA Class II ·initiated 28 Dec 2012

  Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.

510(k) Number

K110406 ↗

FDA Product Code

NQI

Device Class

Class II

Regulation

21 CFR Part 866.6020

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Celltracks Autoprep System MODEL:9541

  Class I

  FDA 510(k) K100684 Active Cleared 26 Aug 2010

• Cellsearch Circulating Tumor Cell Kit

  Class II

  FDA 510(k) K062013 Active Cleared 14 Dec 2006

• Cellsearch Epithelial Cell Control Kit

  Class II

  FDA 510(k) K040898 Active Cleared 28 Jun 2004

• Celltracks Analyzer II System

  Class II

  FDA 510(k) K130794 Active Cleared 20 Jun 2013

• Celltracks Autoprep System

  Class II

  FDA 510(k) K122821 Active Cleared 13 Dec 2012

• Cellsearch Circulating Tumor Cell Kit Model 7900001 Open recall

  Class II

  FDA 510(k) K103502 Active Cleared 21 Dec 2010

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