Z-1949-2013Class II

CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below

Name: Z-1949-2013 CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below
Creator: Veridex, LLC
Published: 2012-12-28
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2012-12-28 / Terminated / root cause: software

FDA source

Veridex, LLC began a recall of CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with... on 2012-12-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1949-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-28
Posted: 2013-08-10
Terminated: 2015-08-11
Recalling firm: Veridex, LLC
Product: 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.
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
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.
Root cause tag: software
FDA root cause: Software design
Action: Veridex sent an Important Product Correction Notification letter dated December 28, 2012, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.
Quantity in commerce: US: 82 Units; Ex-US 78 Units.
Distribution: Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
Product codes and lots: CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1949-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1949-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-10
Z-1950-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-10

Product code NQI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)