Events

Recall of Iron Assay performed with the Dimension & Dimension Vista Systems. An in vitro diagnostic medical device (IVD)

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-01186-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01186-1
  • 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 become aware of deferoxamine interference with dimension and dimension vista iron assays at a different concentration than listed in the instructions for use (ifu). deferoxamine is listed in the dimension and dimension vista ifu’s as a non-interfering substance. the concentration that was used for interference testing (3.8 nmol/l) is significantly below what would be expected in clinical practice. siemens healthcare diagnostics is providing an update to the limitation of procedure section for the dimension and dimension vista iron assays instructions for use (ifu) to indicate that: patients treated with metal-binding drugs (e.G. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay.The reference to deferoxamine at a concentration of 3.8 nmol/l will be removed from the non interfering substances section of the ifu.
  • Action
    Siemens is advising users that the Limitation of Procedure section of the Instructions for Use (IFU) will be updated to include "patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay". This information supersedes the current IFU while the IFU is being updated. Siemens is not recommending a review of previous results however a review is at the discretion of the laboratory director.

Device

Iron Assay performed with the Dimension & Dimension Vista Systems. An in vitro diagnostic medical...
  • Model / Serial
    Iron Assay performed with the Dimension & Dimension Vista Systems. An in vitro diagnostic medical device (IVD)Dimension Iron AssayCatalogue Number: DF85Siemens Material Number: 10444945Dimension Vista Iron AssayCatalogue Number: K3085Siemens Material Number: 10445135All lots (including all future lots until the IFU is updated)ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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