Events

Recall of Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

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
    32268
  • Event Risk Class
    Class 2
  • Event Number
    Z-1015-05
  • Event Initiated Date
    2005-05-26
  • Event Date Posted
    2005-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39477
  • 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
    Adverse trend in stability, controls biased or out of range.
  • Action
    Recall was initiated by phone using a script, to be followed up with a letter and response form.

Device

Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
  • Model / Serial
    Lots 302 and 303
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.
  • Product Description
    Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
  • Manufacturer
    Diagnostic Products Corp

Manufacturer

Diagnostic Products Corp
  • Manufacturer Address
    Diagnostic Products Corp, 5210 Pacific Concourse Dr, Los Angeles CA 90045-6900
  • Source
    USFDA