Events

Recall of Siemens ADVIA Centaur Systems, Dimension Vista Systems, IMMULITE Systems

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 Inc.

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
    20996
  • Event Initiated Date
    2017-01-09
  • 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, 55 Hugo Johnston Drive, Penrose, Auckland
  • Reason
    The manufacturer has confirmed that the presence of dhea-s (a metabolite of dhea, a steroid hormone that may be used as part of in vitro fertilization (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens ADVIA Centaur Systems, Dimension Vista Systems, IMMULITE Systems
  • Model / Serial
    Model: , Affected: ADVIA Centaur Progesterone1 - All Lots, Dimension Vista LOCI Progesterone2 - All Lots, IMMULITE/IMMULITE 1000 Progesterone - All Lots, IMMULITE 2000 Progesterone3 - All Lots
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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