Z-0819-2010

CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company

Name: Z-0819-2010 CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company
Creator: Veridex, LLC
Published: 2009-08-12
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2009-08-12 / Terminated / root cause: packaging

FDA source

Veridex, LLC began a recall of CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company on 2009-08-12. The reason FDA records is "Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0819-2010
Status: Terminated
Initiated: 2009-08-12
Posted: 2010-02-23
Terminated: 2012-07-18
Recalling firm: Veridex, LLC
Product: CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Reason for recall: Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).
Quantity in commerce: 1641 in US, 380 internationally.
Distribution: Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.
Product codes and lots: Lot number 0019, Exp 1/8/2010; 0019B, Exp 1/8/2010; 0039, Exp 3/16/2010; 0059, Exp 3/6/2010, 0079, Exp 2/20/2010; 0099, Exp 6/24/2010.

Product code NQI

K073338Class IICellsearch Circulating Tumor Cell KitVeridex, LLC / cleared 2008-02-26

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)