Events

Recall of IMMULITE/IMMULITE 1000 - Cortisol Assay - 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-2014-RN-01023-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01023-1
  • 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 has identified that immulite/immulite 1000 cortisol kit demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. the positive bias was also observed in quality control materials and may result in values outside the established ranges.. the observed positive bias in cortisol values may potentially lead to additional investigation of adrenal status.
  • Action
    Siemens are advising users to discontinue use and discard any remaining kits. The issue has been resolved with IMMULITE/IMMULITE 1000 Cortisol kit lots 384 and above (supplied since 1 August, 2014). A look back of previously generated results is at the discretion of laboratory. This action has been closed-out on 12/08/2016.

Device

IMMULITE/IMMULITE 1000 - Cortisol Assay - An in vitro diagnostic medical device (IVD)

Manufacturer

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