Events

Recall of Siemens Immulite Androstenedione

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
    16460
  • Event Initiated Date
    2014-03-27
  • 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
    Siemens healthcare diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/ml (19.2 nmol/l) with the immulite/immulite 1000 and immulite 2000/immulite 2000 xpi androstenedione assays (lkao1, l2kao2)., siemens has determined that these lots are linear up to a concentration of 5.5 ng/ml (19.2 nmol/l), instead of 10 ng/ml (34.9 nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5 ng/ml (19.2 nmol/l) and 10 ng/ml (34.9 nmol/l) will detect this issue., this is a follow up to the above where siemens is now providing supplementary information regarding the dilution of androstenedione samples >5.5ng/ml (19.2 nmol/l) as an alternative to verifying samples with an alternate method.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Immulite Androstenedione

Manufacturer

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