System, Immunomagnetic, Circulating Cancer Cell, Enumeration

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.

CELLTRACKS ANALYZER II (Product Code 9555)

Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.

CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below.

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.

CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below.

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.

CellTracks Analyzer II.

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.

CellSearch Circulating Tumor Cell Kit (Epithelial) IVD

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.

Cell Search Circulating Tumor Cell Kit (Epithelial)

An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cy

High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001)

Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.