Events

Recall of ADVIA Chemistry Systems. 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-2013-RN-01158-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01158-1
  • 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
    When the system switches from the primary reagent pack to the back-up reagent pack, the software may result in the auto-calibration or qc to utilise the incorrect values for the blank and standard. the systems should not pass calibration and qc, however, the software version affected may allow the system to pass calibration and qc. this may result in a shift in patient results which can be observed through patient trending.
  • Action
    A software upgrade will be implemented for ADVIA systems 1800 and 2400 as a permanent fix. As the ADVIA 1650 is planned to be made obsolete effective March 2014 the software update has not been designed for this device. Siemens is providing users with work around instructions to follow as an interim measure. A review of previously generated results is at the discretion of the laboratory director. Thia action has been closed on 28/01/2016

Device

ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)ADVIA 1650Software versions: V3.52, V4.01ADVIA 1800Software version: V2.01ADVIA 2400Software version: V4.01Siemens Reference Number: CHSW 13-03ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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