Events

Recall of Siemens ADVIA Chemistry XPT 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
    20113
  • Event Initiated Date
    2016-05-05
  • 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
    Multiple issues have been identified with the advia® chemistry xpt systems with software version 1.0.3 (smn 11127538) and software version 1.1 (smn 11127561) that may affect the day-to-day behaviour and/or workflow of the system. issues include:, 1. all levels of qc run when only 1 is selected in start/restart window, 2. qc selection error, 3. workstation services may restart, and, 4. assay utilization is not updating for ise tests.
  • Action
    Software to be upgraded

Device

Siemens ADVIA Chemistry XPT Systems

Manufacturer

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