BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1950-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1950-2013
    Event ID
    64304
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Veridex, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    December 28, 2012
    Classification Date
    August 10, 2013
    Termination Date
    August 11, 2015
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606, United States

    Description

    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.

    Reason

    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.

    Code Info

    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555).

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.

    Quantity

    US: 70 Units; Ex-US 76 Units