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    CELLTRACKS AUTOPREP SYSTEM

    FDA Adverse Event
    Other ·VERIDEX, LLC·Product code GKH·March 11, 2009

    CELLTRACKS AUTOPREP SYSTEM

    FDA Adverse Event
    Malfunction ·VERIDEX LLC·Product code GKH·April 30, 2009

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    FDA Adverse Event
    Malfunction ·VERIDEX, LLC·Product code NQI·May 19, 2008

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    FDA Adverse Event
    Malfunction ·VERIDEX LLC·Product code NQI·June 16, 2008

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    FDA Adverse Event
    Other ·VERIDEX LLC·Product code NQI·August 4, 2008

    GENESEARCH BREAST LYMPH NODE ASSAY

    FDA Adverse Event
    Other ·VERIDEX LLC·Product code OCB·February 14, 2008

    Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·April 17, 2007

    CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.

    FDA Recall
    Terminated ·Veridex, LLC·Product code GKH·May 6, 2009

    CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·August 12, 2009

    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·August 21, 2013

    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·August 21, 2013

    CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    FDA Recall
    Terminated ·Veridex, LLC·Product code GKH·May 19, 2010

    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·December 28, 2012

    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·December 28, 2012

    CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·August 17, 2011

    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.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·January 8, 2014

    Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003

    FDA Recall
    Terminated ·Veridex, LLC·Product code NRS·November 9, 2010

    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·May 15, 2015

    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·August 26, 2015

    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.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014