Events

Recall of ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3

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

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-01205-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01205-1
  • 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 identified a number of issues that may affect the operation and workflow of the system.A summary of the issues is listed below. however this is not a comprehensive list. please refer to the customer letter for the full details.- if the assay is being run with multiple replicates defines, the analyser reports the results as a mean for all replicate results. this may lead to incorrect diagnosis. if the final result rule is disabled, it may lead to delayed diagnosis of hepatitis c viral infection or hiv. if the manual final result rule is being used with multiple replicates, it may lead to a missed diagnosis of toxoplasmosis. if you are running samples with replicates set to any value greater than 1, siemens recommends a look back of all results that may be affected.- if there is a unit change in test definition for assay & the delta check functionality is enabled, it may lead to incorrect flagging.
  • Action
    Siemens is advising users that a number the issues may be corrected with software upgrade V1.1. The remaining issues will be corrected in a future software update, and Siemens is providing work around instructions as a interim measure. Siemens is recommends a lookback of patient results if users are running samples with replicates greater than 1 and discussing the customer letter with the Laboratory Director.

Device

ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3
  • Model / Serial
    ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3Siemens Material Number (SMN): 10711433Software version 1.0.1Bundle: 1.0.912 SMN: 10819704Software version 1.0.2Bundle: 1.0.1086 SMN: 11219806Software version 1.0.3Bundle: 1.0.1108 SMN: 11220781ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA