Recall of IMMULITE 2000 Intact PTH kit

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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Radioimmunoassay, Parathyroid Hormone - Product Code CEW
  • Reason
    High bias noted in samples collected with edta. indication is to not run samples with edta.
  • Action
    Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.


  • Model / Serial
    Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC
  • Product Description
    IMMULITE 2000 Intact PTH kit
  • Manufacturer


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