Recall of Device Recall ARCHITECT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories, Inc.

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 2
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Reason
    If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
  • Action
    Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.


  • Model / Serial
    All Serial numbers
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri, Louisiana, Oregon, Wisconsin, Hawaii, Connecticut, New Hampshire, Massachusetts, Washington, South Carolina, Mississippi, Alabama, and Tennessee, and the following foreign countries: Austria, Denmark, Germany, Italy, Poland, South Africa, Sweden, England, Colombia, Australia, Japan, New Zealand, Belgium, Finland, Greece, Netherlands, Portugal, Romania, Turkey, Canada, Mexico, Hong Kong, Korea, Taiwan, Czech Republic, France, Israel, Norway, Saudi Arabia, Spain, United Arab Emirates, Brazil, Venezuela, India, Malaysia, and Thailand.
  • Product Description
    ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
  • Manufacturer


  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75015-2020
  • Source