Events

Recall of CentraLink Data Management Systems with software versions v13x, v14x, v15x. 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-2016-RN-01576-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01576-1
  • 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
    This issue can only occur when the centralink data management system is connected to the advia workcell or advia labcell automation system and the laboratory information system (lis) does not include sampletype in work order downloaded to centralink. if the automated task to download samples to the laboratory automation system (las) processes immediately after the order is received from the lis, there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type. on advia automation, the value “default” will be downloaded instead of the sample type and this may affect activities that are based on sample type, e.G. sorting for centrifugation based on sample designations. the activity may not be triggered if “default” is received.The risk to health due to this issue is remote given the timing required for the issue to occur and the need for an activity to fail such that an erroneously believable result occurs.
  • Action
    Siemens is recommending that the LIS specify the sample type in the work order, as the CentraLink system is designed to operate in an environment in which the sample type is specified in the work order that is downloaded from the LIS. A Siemens Technical Support Representative will contact laboratories to review their CentraLink configuration. If the LIS does not include sample type information in the sample orders downloaded to CentraLink and Pre-Tests assigned by sample type are configured on the ADVIA Automation System, the representative will update the configuration.

Device

CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnosti...
  • Model / Serial
    CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnostic medical device (IVD).Multiple Siemens Material NumbersARTG Number: 224615
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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