Z-1195-2014Class II

CELLTRACKS ANALYZER II (Product Code 9555)

Name: Z-1195-2014 CELLTRACKS ANALYZER II (Product Code 9555)
Creator: Veridex, LLC
Published: 2014-01-08
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2014-01-08 / Terminated / root cause: design

FDA source

Veridex, LLC began a recall of CELLTRACKS ANALYZER II (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a... on 2014-01-08. FDA classified it as Class II and gives the reason as "Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1195-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-03-13
Terminated: 2017-07-06
Recalling firm: Veridex, LLC
Product: CELLTRACKS ANALYZER II (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS AUTOPREP System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Reason for recall: Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.
Root cause tag: design
FDA root cause: Device Design
Action: Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339.
Quantity in commerce: 19 units
Distribution: Worldwide Distribution - USA Nationwide
Product codes and lots: First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555 Serial numbers: CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1195-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1195-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12

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)