Events

Recall of ADVIA Centaur PSA 100 test kit and 500 test kit. 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-00005-2
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-01-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00005-2
  • 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 has confirmed that the lots ending in 263 and above are not meeting the current high-dose hook effect expectation that patient samples with total psa levels as high as 10,000 ng/ml (µg/l) will assay greater than 100 ng/ml (µg/l) as indicated in the instructions for use (ifu).Based on siemens’ internal testing, samples with total psa concentrations between 4200 ng/ml (µg/l) and 8400 ng/ml (µg/l) do not assay >100 ng/ml (µg/l) but instead result in falsely depressed concentrations of approximately 50 ng/ml (µg/l) to 94 ng/ml (µg/l).The disease state would be clinically apparent in a patient with a psa level >4200 ng/ml (ìg/l). a review of previously generated results due to this issue is at the discretion of the laboratory.
  • Action
    The sponsor is advising users to review the customer letter. Customers can continue to use this product with the understanding that patient samples with total PSA levels between 4200 and 8400 ng/mL (µg/L) will result in falsely depressed results between 50 and 94 ng/mL (µg/L). Customers may opt to change their dilution point based on their patient population and individual laboratory needs.

Device

ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD)Siemens Material Numbers: 10310292 and 10310293Lot Numbers: All lots ending in 263 and aboveARTG Number: 175243
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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