Events

Recall of Siemens ADVIA Centaur BR Assay for CA 27.29

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
    13767
  • Event Initiated Date
    2012-11-07
  • 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 provided information regarding new room temperature operating requirements., the operating range of the advia centaur systems is 18°c to 30°c. the specified assays can produce inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.
  • Action
    Instructions for use to be updated

Device

Siemens ADVIA Centaur BR Assay for CA 27.29

Manufacturer

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