Events

Recall of Siemens ADVIA Centaur Folate

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
    16467
  • Event Initiated Date
    2014-03-28
  • 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
    Manufacturer has confirmed two different sets of complaints regarding the advia centaur systems folate asay:, folate lot 223: siemens confirmed one set of customer complaints with the advia centaur systems folate assay, kit lots ending in 223. customers observed that the bio-rad liquichek™ and bio-rad lyphochek™ immunoassay plus folate serum controls may go out of range low with the advia centaur systems folate assay, kit lots ending in 223., folate lot 219 whole blood bias: in addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results when moving from advia centaur systems folate assay, kit lots ending in 219 to kit lots ending in 222, 224, 225, 226 and/or 227.
  • Action
    Product to be destroyed

Device

Siemens ADVIA Centaur Folate
  • Model / Serial
    Model: 10310308 10325366 10331250 and 10340209, Affected: kit lots ending in 219, 222, 223, 224, 225, 226 and 227
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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