Z-1102-2007

Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC...

Name: Z-1102-2007 Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC...
Creator: Veridex, LLC
Published: 2007-04-17
License: https://open.fda.gov/license/

Veridex, LLC / initiated 2007-04-17 / Terminated

FDA source

Veridex, LLC began a recall of Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA... on 2007-04-17. The reason FDA records is "An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1102-2007
Status: Terminated
Initiated: 2007-04-17
Posted: 2007-07-24
Terminated: 2007-12-06
Recalling firm: Veridex, LLC
Product: Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Reason for recall: An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
FDA root cause: Other
Action: All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.
Quantity in commerce: Lot 0036: 468 kits; Lot 0036A: 197 kits
Distribution: The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.
Product codes and lots: Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.

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)