Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: Recalled by Veridex, LLC Due to Veridex, LLC has received a report that a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Veridex, LLC directly.
Affected Products
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.
Quantity: US: 70 Units; Ex-US 76 Units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Veridex, LLC
Veridex, LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report