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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

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.
Recall Number Z-1195-2014
Classification Class II
Code Info First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555 Serial numbers: CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024
Product Distributed Qty 19 units
Reason For Recall Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II®.

Event Detail

Event Id 67447
Product Type Devices
Status Ongoing
Recalling Firm Veridex, LLC
City Raritan
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide
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