Z-1949-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2013
- Initiation Date
- December 28, 2012
- Termination Date
- August 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 82 Units; Ex-US 78 Units.
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
Code Information
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541).