Events

Recall of Siemens Advia Centaur XPT

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
    18951
  • Event Initiated Date
    2015-08-03
  • 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
    Siemens healthcare diagnostics has identified multiple issues with the advia centaur® xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) and v1.0.2 (bundle 1.0.1086 smn 11219806)., when running thcg samples with an initial dilution of 1 to 200, without processing neat specimens, it is potentially possible to miss a positive thcg value where the neat value is less than 1000. a lookback of 48 hours is recommended for negative thcg samples if neat values were not initially run for thcg and large dilutions were employed., there is the extremely unlikely potenial to transpose patient results when running in rack order mode without positive sample identificiation., similarly a lookback of 48 hours for any instruments running in this mode is recommended.
  • Action
    Software to be upgraded

Device

Siemens Advia Centaur XPT

Manufacturer

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