Veridex, LLC
United StatesFDA applicant, unverified
- Devices
- 12
- FDA recalls
- 10
At a glance
Market reach
- United States
- FDA recalls
What Veridex, LLC makes
Veridex, LLC manufactures automated systems for detecting circulating tumor cells, including the CellTracks Autoprep System and CellSearch Circulating Tumor Cell Kits. These products are designed to isolate and analyze epithelial cells from blood samples, supporting cancer diagnostics and monitoring. The CellTracks Analyzer II System processes and analyzes cell samples, while control kits ensure assay validation. Modifications to the CellSearch Circulating Tumor Cell Kit are also part of the portfolio.
The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II medical devices. These systems are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 12 devicesFDA recalls
FDA recall records list 10 recalls initiated by Veridex, LLC, the earliest on 2007-04-17 and the most recent on 2015-05-15. By recorded status: 10 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 15 May 2015 Z-2406-2015 Class II Terminated 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.
2014
- 8 Jan 2014 Z-1195-2014 Class II Terminated Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.
2012
- 28 Dec 2012 Z-1949-2013 Class II Terminated 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.
Full distribution text
- 28 Dec 2012 Z-1950-2013 Class II Terminated 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.
Full distribution text
- 28 Dec 2012 Z-1949-2013 Class II Terminated 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.
2011
- 17 Aug 2011 Z-1004-2012 Unclassified (pre-2012) Terminated 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.
2010
- 9 Nov 2010 Z-1472-2011 Unclassified (pre-2012) Terminated 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.
- 19 May 2010 Z-2175-2010 Unclassified (pre-2012) Terminated Complaints of patient sample carryover.
2009
- 12 Aug 2009 Z-0819-2010 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 6 May 2009 Z-1734-2009 Unclassified (pre-2012) Terminated Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
- 12 Aug 2009 Z-0819-2010 Unclassified (pre-2012) Terminated 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.
2007
- 17 Apr 2007 Z-1102-2007 Unclassified (pre-2012) Terminated An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
Full distribution text
- 17 Apr 2007 Z-1102-2007 Unclassified (pre-2012) Terminated An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
Frequently asked questions
How many devices does Veridex, LLC have in the registry?
The registry currently lists 12 devices for Veridex, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Veridex, LLC's devices?
Among its 12 most recently registered devices, Veridex, LLC has devices listed in FDA 510(k) (12 devices).
What risk classes do Veridex, LLC's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Veridex, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Veridex, LLC?
FDA recall records list 10 recalls initiated by Veridex, LLC, the most recent initiated on 15 May 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Veridex, LLC in the registry?
The most recently registered devices listed for Veridex, LLC include CELLTRACKS AUTOPREP SYSTEM MODEL:9541, CELLSEARCH CIRCULATING TUMOR CELL KIT, CELLSEARCH EPITHELIAL CELL CONTROL KIT and CELLTRACKS AUTOPREP SYSTEM.