Z-1472-2011

Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003

Name: Z-1472-2011 Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
Creator: Veridex, LLC
Published: 2010-11-09
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2010-11-09 / Terminated / root cause: manufacturing process

FDA source

Veridex, LLC began a recall of Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003 on 2010-11-09. The reason FDA records is "There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit". 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-1472-2011
Status: Terminated
Initiated: 2010-11-09
Posted: 2011-03-01
Terminated: 2014-03-28
Recalling firm: Veridex, LLC
Product: Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
Product code: NRS Control Material, Blood Circulating Epithelial Cancer Cell
Reason for recall: There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.
Quantity in commerce: 122 US, 28 International
Distribution: Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.
Product codes and lots: Lot C512; Product code 7900003

Product code NRS

K040898Class IICellsearch Epithelial Cell Control KitVeridex, LLC / cleared 2004-06-28

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)