Veridex, LLC
Raritan, NJ, US
Veridex, LLC appears in FDA device records in Raritan, NJ. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 10 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Veridex, LLC between 2004 and 2013. The busiest year on record is 2005, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | NQI | Substantially Equivalent | |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | NQI | Substantially Equivalent | |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | NQI | Substantially Equivalent | |
| K113181 | CELLTRACKS ANALYER II | NQI | Substantially Equivalent | |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | NQI | Substantially Equivalent | |
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | GKH | Substantially Equivalent | |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | Substantially Equivalent | |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | Substantially Equivalent | |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | Substantially Equivalent | |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | Substantially Equivalent | |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | NQI | Substantially Equivalent | |
| K040898 | CELLSEARCH EPITHELIAL CELL CONTROL KIT | NRS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2406-2015 | Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood. | Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells. | Class II | Terminated | |
| Z-1195-2014 | 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. | Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II. | Class II | Terminated | |
| Z-1950-2013 | 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. | 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. | Class II | Terminated | |
| Z-1949-2013 | 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. | 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. | Class II | Terminated | |
| Z-1004-2012 | 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. | Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II. | Terminated | ||
| Z-1472-2011 | Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003 | There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit. | Terminated | ||
| Z-2175-2010 | 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. | Complaints of patient sample carryover. | Terminated | ||
| Z-0819-2010 | CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company. | Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results. | Terminated | ||
| Z-1734-2009 | 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. | Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System. | Terminated | ||
| Z-1102-2007 | 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 | An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain