Veridex, LLC recalls CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluores

Recalled March 19, 2014 · FDA recall Z-1195-2014 · Veridex

Hazard

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

Units

19 units

Sold at

Worldwide Distribution - USA Nationwide

Description

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

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.

Manufacturer(s)

Veridex, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →