Events

Recall of Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD) Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL Cholesterol

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-00350-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00350-1
  • 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 n- acetylcysteine (nac) and metamizole (dipyrone) interference with trinder and trinder-like reaction assays. the trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a coloured quinone product. siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving n- acetylcysteine (nac) or metamizole. nac is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity. the potential exists for reporting falsely depressed results for the assays affected. baseline values before administration of the nac or metamizole therapy would not be affected. it is extremely unlikely these assays would be requested during assessment of acetaminophen overdose and nac treatment.
  • Action
    Siemens is advising the IFUs for the relevant assays will be updated to indicate that "Venipuncture should occur prior to Metamizole/N-Acetyl Cysteine (NAC) administration due to the potential for falsely depressed results." A review of previously generate results is at the discretion of the Laboratory Director.

Device

Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (...
  • Model / Serial
    Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL CholesterolAll Lot Numbers affectedARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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