Events

Recall of ADVIA Centaur Systems Insulin assay

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
    21315
  • Event Initiated Date
    2017-04-11
  • 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 identified that current in-date lots of advia centaur systems insulin recover approximately 40% higher than the world health organization (who) 1st irp 66/304 standardization based on slope values. this issue has been corrected and standardization to who 1st irp 66/304 has been restored beginning with advia centaur iri readypack kit lots ending in 201 when paired with iri calibrator kit lots ending in 02, which will be available by may 2017.
  • Action
    Manufacturer to issue advice regarding use

Device

ADVIA Centaur Systems Insulin assay

Manufacturer

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