Company: Veridex, LLC
Date of Enforcement Report: 8/21/2013
Class ll:
PRODUCT
1. 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. Recall Number Z-1949-2013
2. CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Z-1950-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Veridex, LLC Raritan, NJ on 12/28/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1. US: 82 Units; Ex-US 78 Units.
2. US: 70 Units; Ex-US 76 Units
DISTRIBUTION
Nationwide and Internationally
___________________________________
