Events

Recall of Siemens Advia Centaur Calibrator E

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
    17461
  • Event Initiated Date
    2014-10-01
  • 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
    Siemens healthcare diagnostics has identified a positive bias for calibrator e kit lots ending in 38 and 39 with the advia centaur systems cortisol and progesterone assays compared to the respective master curves., the observed positive bias with advia centaur systems cortisol and progesterone assays with calibrator e kit lots ending in 38 and 39 does not impact their clinical utility. the biases affect regions of the curve that are not clinically relevant in the investigation or monitoring of endocrine disorders or other uses.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Advia Centaur Calibrator E
  • Model / Serial
    Model: Catalogue Numbers: 10309079 (2 pack), 10321075 (6 pack), 10335532 (6 pack-REF), Affected: Kit lots ending in 38 (exp 29-Nov-2014), and 39 (15-May-2015)
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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