Z-2406-2015Class II

Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of...

Name: Z-2406-2015 Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of...
Creator: Veridex, LLC
Published: 2015-05-15
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2015-05-15 / Terminated

FDA source

Veridex, LLC began a recall of Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood on 2015-05-15. FDA classified it as Class II and gives the reason as "Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2406-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Posted: 2015-08-18
Terminated: 2016-03-30
Recalling firm: Veridex, LLC
Product: Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Reason for recall: Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
FDA root cause: Under Investigation by firm
Action: Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex.
Quantity in commerce: 1560 kits
Distribution: Nationwide Distribution.
Product codes and lots: Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2406-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2406-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-18

Product code NQI

K103502Class IICellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC / cleared 2010-12-21

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)