Events

Recall of Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size 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
    27020
  • Event Risk Class
    Class 3
  • Event Number
    Z-1219-03
  • Event Initiated Date
    2003-07-31
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29019
  • 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
    Helicobacter Pylori - Product Code LYR
  • Reason
    Kits had parts in them that did not belong in the kit.
  • Action
    Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.

Device

Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
  • Model / Serial
    Lot 118
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
  • Product Description
    Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
  • Manufacturer
    Diagnostic Products Corp

Manufacturer

Diagnostic Products Corp
  • Manufacturer Address
    Diagnostic Products Corp, 5700 West 96th Street, Los Angeles CA 90045
  • Source
    USFDA