Recall Z-1195-2014— Veridex, LLC

Name: FDA recall Z-1195-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-08

Class II · Terminated

Class II FDA medical device recall by Veridex, LLC, initiated 2014-01-08, terminated 2017-07-06. It names 2 FDA 510(k) clearances: K130794, K050145. Product: CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.. Reason: Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿..

Recalling firm: Veridex, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Terminated: 2017-07-06
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K130794 — CELLTRACKS ANALYZER II SYSTEMVeridex, LLC·cleared 2013-06-20
K050145 — CELLTRACKA ANALYZER IIImmunicon Corp.·cleared 2005-03-15

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

CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

Reason for recall

Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.

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