Events

Recall of Device Recall ADVIA Centaur XPT Immunoassay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    Recall
  • Event ID
    74309
  • Event Risk Class
    Class 2
  • Event Number
    Z-2256-2016
  • Event Initiated Date
    2016-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147129
  • 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, thyroid-stimulating hormone - Product Code JLW
  • Reason
    Eight (8) issues were identified which may affect the results generated by the system software version.
  • Action
    On May 26, 2016, Siemens Healthcare Diagnostics Inc. distributed an Urgent Medical Device Correction notices to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers are advised to complete and return the Field Correction Effectiveness Check form within 30 days via fax to (312) 275-7795. For questions contact your local Siemens technical support representative.

Device

Device Recall ADVIA Centaur XPT Immunoassay System
  • Model / Serial
    none
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Republic Korea, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom & Vietnam.
  • Product Description
    ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). || Product Usage: || This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA