Events

Recall of Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).

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-01117-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01117-1
  • 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 determined that the concentrations for some of the cross reactants listed in the specificity section of the dimension opiates assay instructions for use and the cross-reactivity section of the dimension vista opiates assay instructions for use are incorrect. siemens has revised the concentrations, which will enable the correct interpretation on how cross reactants can affect test results. the instructions for use for the opiates assay will be updated with the correct concentrations when siemens completes their investigation of the issue.
  • Action
    Siemens is advising users to review the revised cross-reactant concentrations for Levallorphan, Levorphanol, Nalorphone and Oxycodone that are provided in the recall correspondence with their Medical Director. The decision to perform a look-back should be at the discretion of the Medical Director. Siemens will be updating the IFU with the revised concentrations once they have completed their investigation of the issue.

Device

Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).
  • Model / Serial
    Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).Assay Name: Dimension OpiatesCatalogue Number: DF93ASiemens Material Number: 10444923Assay Name: Dimension Vista OpiatesCatalogue Numbers: K5093 Siemens Material Number: 10445114All lots, including all future lots until the IFU is updatedARTG Number: 182221
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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