Events

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
    Recall
  • Event ID
    28501
  • Event Risk Class
    Class 3
  • Event Number
    Z-0724-04
  • Event Initiated Date
    2004-02-23
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32007
  • 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.

Device

IMMULITE 2000 Intact PTH kit
  • Model / Serial
    Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
    Diagnostic Products Corp

Manufacturer

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