Events

Recall of Immulite 1000 CEA || Catalog No. LKCE1

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

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
    29084
  • Event Risk Class
    Class 2
  • Event Number
    Z-0972-04
  • Event Initiated Date
    2004-05-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33116
  • 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
    System, Test, Carcinoembryonic Antigen - Product Code DHX
  • Reason
    Instabililty.
  • Action
    Notice was made via email or telephone. Users are to discard kits.

Device

Immulite 1000 CEA || Catalog No. LKCE1

Manufacturer

Diagnostic Products Corp
  • Manufacturer Address
    Diagnostic Products Corp, 5700 W 96th St, Los Angeles CA 90045-5544
  • Source
    USFDA