Events

Recall of 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
    74162
  • Event Risk Class
    Class 2
  • Event Number
    Z-0072-2017
  • Event Initiated Date
    2016-04-28
  • 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=146584
  • 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
    The advia centaur¿ xpt default setting for the daily maintenance task (daily cleaning procedure) frequency may have the daily maintenance task frequency set to, as needed instead of daily. not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. systems running in a language other than english are not impacted.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated April 28, 2016, to all affected customers. The letter advised customers not to release results generated by the system if quality control results are not within acceptable ranges. Customers were advised to perform the following steps to check the Setting for the Daily Maintenance Task frequency on your instrument: *Open the Maintenance Tab, * Select Daily Maintenance task and * Verify that the Frequency Column is set to "Daily at..". The Daily Maintenance Task frequency setting can only be reset by a Siemens Customer Service engineer. If your instrument is set to "As Needed": Daily Maintenance Task Frequency Setting May be Incorrect. Customers should contact their local Technical Support Center to schedule a visit by your Siemens Customer Service engineer. Customers should also perform the daily maintenance by selecting the Daily Maintenance Task and then selecting Perform on the right bar. In addition, all customers were asked to complete and return the Field Correction Effectiveness Check within 30 days. For questions regarding this recall call 914-631-8000.

Device

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 including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN
  • Product Description
    ADVIA Centaur XPT Immunoassay System
  • 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