Events

Recall of Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Siemens Healthcare Diagnostics Products Limited.

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
    13811
  • Event Initiated Date
    2012-11-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    The manufacturer has confirmed a positive shift in patient medians of approximately 20% with the igf-1 assay. siemens has determined that an initial positive shift of approximately 15% occcurred with immuliate 2000/ immulite 2000 xpi and an additiional positive shift of approximately 5% was observed with immulite 2000/ immulite 2000 xpi leading to the total positive shift of approximately 20%., two potential health risks:, 1. could mask uncontrolled acromegaly and thus affect patient treatment., 2. could lead to an under estimation of hgh deficiency in children with borderline hgh deficiency and potentially result in missed or delayed opportunity to treat with hgh supplement.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

Manufacturer

Siemens Healthcare Diagnostics Products Limited
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA