Events

Recall of Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)

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-2016-RN-01351-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01351-1
  • 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 healthcare diagnostics has confirmed a change in correlation between serum and plasma specimen tubes with the advia centaur vitamin d total assay as compared to instructions for use (ifu). the bias observed between serum and plasma samples has the potential to impact interpretation of vitamin d status in the event the patient's vitamin d level is at or near the cut-offs for deficient versus insufficient or insufficient versus sufficient. this may lead to the initiation of unnecessary vitamin d supplementation and/or additional monitoring of vitamin d levels.
  • Action
    Siemens is advising customers that they may continue to use the ADVIA Centaur Vitamin D Total assay with both serum and plasma specimen types, however, they should consider the bias when evaluating samples in different tube types. Siemens will contact customers when the updated Instructions For Use (IFU) is available for download from Siemens Doc Library.

Device

Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur ...
  • Model / Serial
    Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)Catalogue/SMN Numbers: 10699201 and 10699533Kit Lots ending in:065 - Expiry: 09 Nov 2016066 - Expiry: 30 Jan 2017067 - Expiry: 11 Mar 2017068 - Expiry: 23 Apr 2017069 - Expiry: 21 Jul 2017070 - Expiry: 25 Aug 2017ARTG Number: 175700
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA