Events

Recall of IMMULITE 2000 Total Testosterone 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
    34480
  • Event Risk Class
    Class 2
  • Event Number
    Z-0528-06
  • Event Initiated Date
    2006-01-03
  • Event Date Posted
    2006-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43918
  • 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, Testosterones And Dihydrotestosterone - Product Code CDZ
  • Reason
    The reagent for this kit lot (l2ktw 2,6 126) was manufactured with a raw material that can carryover and interfere with dpc kit immulite 2000 estradiol (l2ke2) causing a false elevation in the observed estradiol concentration.
  • Action
    For domestic customers - the recall is extended to the domestic end user-level. Domestic customers were notified via telephone using a Phone Script (attached in Attachment 5), starting on January 5,2005. Each customer receives a fax-back form and a Technical Bulletin directly after this phone contact. For foreign consignees - the recall is extended to foreign distributors. It is the distributor''s responsibility to extend the recall action to their direct customers. Foreign consignees were notified via e-mail and/or FAX,starting on January 3, 2005.

Device

IMMULITE 2000 Total Testosterone Kit
  • Model / Serial
    CATALOG & LOT NUMBERS: L2KTW 2 Lot 126 (200-test kit) L2KTW 6 Lot 126 (600-test kit)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide in Pakistan, Italy, Cyprus, Turkey, Switzerland, Chile, South Africa, Greece, Mexica, Canada, Thialand, Germany, India, United Arab Emirates, Hungary, Israel, Portugal, Taiwan, Austria, Saudi Arabia, Malaysia, Hong Kong, India, Colombia, Argentina, Australia, Costa Rica, Czech Republic, Spain, France, Panama, Brazil, Netherlands, Poland, Sweden, United Kingdom, & El Salvadon.
  • Product Description
    IMMULITE 2000 Total Testosterone Kit
  • Manufacturer
    Diagnostic Products Corp.

Manufacturer

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