Z-1004-2012

CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled...

Name: Z-1004-2012 CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled...
Creator: Veridex, LLC
Published: 2011-08-17
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2011-08-17 / Terminated / root cause: software

FDA source

Veridex, LLC began a recall of CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and... on 2011-08-17. The reason FDA records is "Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II". 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-1004-2012
Status: Terminated
Initiated: 2011-08-17
Posted: 2012-02-13
Terminated: 2015-06-17
Recalling firm: Veridex, LLC
Product: CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Reason for recall: Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.
Root cause tag: software
FDA root cause: Software design
Action: Veridex, LLC sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated August 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides procedure sheets with step by step directions for customers to follow. Additionally, a Confirmation of Receipt form was enclosed for customers to complete and return to the firm. Contact Customer Technical Services at 1-877-837-4339 for questions regarding this notice.
Quantity in commerce: 37 Units
Distribution: Worldwide Distribution.
Product codes and lots: K050145 (March 15, 2005); K060110 (March 16, 2006) Product code 9555

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)