Events

Recall of ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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
    RC-2015-RN-00111-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00111-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has determined through an internal investigation that some assays do not align with the representative data published in the instructions for use (ifu) for on-board stability, calibration frequency, and/or interference.
  • Action
    Siemens is requesting their customers to verify that the current IFU version for methods in use in the laboratory is being followed. Navigate to the Siemens Document Library for the current version of the IFU: https://www.healthcare.siemens.com/doclib. For on-board stability and calibration frequency changes, ensure that the ADVIA Chemistry system is programmed to reflect the changes indicated in the IFU. This action has been closed-out on 03/08/2016.

Device

ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical ...
  • Model / Serial
    ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical device (IVD)Multiple Siemens material numbersARTG number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA