Events

Recall of Veridex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Veridex, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38206
  • Event Risk Class
    Class 3
  • Event Number
    Z-1102-2007
  • Event Initiated Date
    2007-04-17
  • Event Date Posted
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53161
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    in vitro diagnostic - Product Code NQI
  • Reason
    An increased incidence of aggregates was observed in lot 0036 and 0036a. the presence of aggregates will cause customers to invalidate patient results.
  • 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.

Device

Veridex
  • Model / Serial
    Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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
  • Manufacturer
    Veridex, LLC

Manufacturer

Veridex, LLC
  • Manufacturer Address
    Veridex, LLC, 33 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA