Reported Aug 21, 2013 · Terminated
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general…
Veridex, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Veridex, LLC · 1001 US Route 202 · Raritan, NJ · 08869-0606
Is this the product you have?
- CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below
- Product UsageThe 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
- Lot codes and dates
- CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below)
- Product CodeCT1476B (9555)
- Amount recalled
- US: 70 Units; Ex-US 76 Units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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