Recall of ADVIA Centaur CP System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics.

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
    Immunoassay Analyzer - Product Code JJE
  • Reason
    Sample/patient mis-identification (software defect)-the system can associate a test result and sample identification (sid) with an incorrect patient name when the patient demographics feature is used and the patient identification (pid) field is left blank.
  • Action
    On 8/04/06, a Support Bulletin was e-mailed to all affected Bayer HealthCare LLC Branches worldwide in order to inform them of the issue and to provide them with instructions for this 'field correction' until the new software version is issued. A Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customers worldwide.



  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source