Recall of CentraLink Database Management System, version 14.0.4 (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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    A system database anomaly has been identified that may cause instrument results in certain situations to not be accepted by the centralink system. at the same time, the operator may receive no indication of this rejection.
  • Action
    End users are being provided with work around instructions to ensure all patient results are reported. Siemens will be providing a future correspondence once a correction has been designed.


  • Model / Serial
    CentraLink Database Management System, version 14.0.4 (An in vitro diagnostic medical device (IVD))Catalogue Numbers: 10810208, 10810209, 10810210, 10810211, 10811596, 10811597, 10811598, 10811599, 10811600 & 10811601
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source