Events

Recall of ADVIA Centaur Folate Assay

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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
    RC-2014-RN-00369-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00369-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Siemens has confirmed one set of customer complaints related to the performance of the advia centaur systems folate assay, kit lots ending in 223. customers observed that the third party controls bio-rad liquichek and bio-rad lyphochek immunoassay plus folate serum controls may give rise to out of range low results with the advia centaur systems folate assay kits.In addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results for advia centaur systems folate assay kit lots ending in 219 compared to kit lots ending in 222, 224, 225, 226 and 227.
  • Action
    Siemens is requesting their customers to discard all kit lots ending in 219 and 223 and to notify Siemens of any replacement needs. Kit lots ending in 222, 224, 225, 226, 227 and above can continue to be used as they provide accurate folate results.

Device

ADVIA Centaur Folate Assay
  • Model / Serial
    ADVIA Centaur Folate AssayLots Numbers Ending In/Expiration Date219 - 25 March, 2014223 - 12 May, 2014ARTG Number: 175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA