Recall of ADVIA Centaur Cyclosporine, DHEA-SO4, Folate and HBc IgM Assays An in vitro diagnostic medical device ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP

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

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-2018-RN-00027-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-22
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 healthcare diagnostics has confirmed through internal investigation that certain assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the advia centaur platforms.
  • Action
    Siemens is advising users to refer to the information provided in the Customer Letter to adjust biotin interference values accordingly for affected assays.

Device

  • Model / Serial
    ADVIA Centaur Cyclosporine, DHEA-SO4, Folate and HBc IgM AssaysAn in vitro diagnostic medical deviceADVIA CentaurADVIA Centaur XPADVIA Centaur XPTADVIA Centaur CPAll Lots of the above assays are affectedARTG Numbers 175242,175698, 175700, 239125
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    DHTGA