Events

Recall of ADVIA Chemistry XPT Systems with software version 1.0.3. 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 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-01049-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01049-1
  • 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 multiple issues with the advia chemistry xpt systems with software version 1.0.3 that may affect the day to day behaviour and/or workflow of the system as follows:auto start-up failingcalibration interval resets when a reagent blank (rbl) is runcontrol definition screen assumes that the range is defined is 2 sd (standard deviation)laboratory information system (lis) communication / laboratory automation (las) issueprinter driver resetsise calibration ranges are too conservative for urine sodium (na)archiving and deletion may failworkstation services may restartwith the alerts generated by the instrument for the scenarios impacting samples, the operator will be aware that a sample may not have been processed and can take action. calibration and control issues are detectable through normal laboratory monitoring practices.
  • Action
    All the issues above except (Issue: Workstation services may restart) are corrected in software version 1.1 which is now available for installation on affected systems. The temporary actions defined in the customer letter should be undertaken until the affected systems have been upgraded to software version 1.1. The remaining issue will be corrected in a future software version.

Device

ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10723034ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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