Z-2175-2010

CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson...

Name: Z-2175-2010 CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson...
Creator: Veridex, LLC
Published: 2010-05-19
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2010-05-19 / Terminated / root cause: manufacturing process

FDA source

Veridex, LLC began a recall of CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating... on 2010-05-19. The reason FDA records is "Complaints of patient sample carryover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2175-2010
Status: Terminated
Initiated: 2010-05-19
Posted: 2010-08-05
Terminated: 2014-05-08
Recalling firm: Veridex, LLC
Product: CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Product code: GKH Apparatus, Automated Blood Cell Diluting
Reason for recall: Complaints of patient sample carryover.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339.
Quantity in commerce: 101 Domestically, 87 Internationally
Distribution: Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
Product codes and lots: Product code 9541

Product code GKH

K040077Class IImmunicon Celltracks Autoprep SystemImmunicon Corp. / cleared 2004-03-12

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)