Events

Recall of PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)

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-00648-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00648-1
  • 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 confirmed an overall average positive bias of approximately 20%-23% across the assay range relative to who 96/670 with the immulite systems psa assays. this positive bias is observed in patient values and the siemens tumor marker controls (tmco).
  • Action
    Siemens are advising users to discontinue use and discard any remaining kits. Replacement kits will be available in July 2013. Siemens is recommending a lookback period of two months of previous test results. For results that were recorded as abnormal, please notify the treating physician. Actions by the clinician may be to reconsider a scheduled biopsy based on the test result taking into account the other factors that made biopsy a consideration.

Device

PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an ...
  • Model / Serial
    PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)Multiple Lot numbers affectedMultiple Catalogue numbers affectedAll kit lots released in February 2012.ARTG Number: 180971
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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