Events

Recall of Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) 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 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-01555-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01555-1
  • 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 confirmed that immulite 2000 / immulite 2000 xpi intact pth kit lot 320 can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml (<2.1 pmol/l) with serum and edta patient samples vs. a reference kit lot. for ipth concentrations of 20 to <50 pg/ml (2.1 to <5.3 pmol/l) the average bias was - 22%, for 50 to <100 pg.Ml (5.3 to <10.5 pmol/l) it was -18% and for =100 pg/ml ( =10.5 pmol/l) it was -5%. depending upon the quality control ranges used by your laboratory, this issue may not be detected by quality controls. when this issue occurs, the potential exists for misinterpretation of ipth levels which may delay determination of the etiology of hypercalcemia or hypocalcemia. clinical impact would be mitigated by correlation to clinical symptomology and additional diagnostic laboratory testing.
  • Action
    Users are advised to discontinue use of and discard Immulite 2000/Immulite 2000 XPi Intact PTH kit lot 320. Affected product will be replaced by Siemens. The review of previously generated results is at the discretion of the laboratory.

Device

Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic...
  • Model / Serial
    Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic medical device (IVD).Test Code: iPTHCatalogue Numbers: L2KPP2, L2KPP6Siemens Material Numbers: 10381441, 10381442Lot Number: 320Expiry: 30 Nov 2016ARTG Number: 179720
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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