Recall of Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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 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
    Enzyme Immunoassay, Theophylline - Product Code KLS
  • Reason
    Defective software media distributed with upgrade software may cause installation failure and systems lock.
  • Action
    Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.



  • Manufacturer Address
    Beckman Coulter Inc, 200 South Kraemer Blvd W 337, Brea CA 92822
  • Source