Events

Recall of Dimension Clinical Chemistry System and Dimension Vista System. 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-2017-RN-00839-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00839-1
  • 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 sulfasalazine and sulfapyridine drug interference in certain assays which use nadh and/or nadph to generate reduction oxidation reactions which produce colorimetric signals.Siemens has confirmed that falsely depressed or falsely elevated results may occur on samples drawn from patients taking sulfasalazine and sulfapyridine. sulfasalazine is the accepted treatment for inflammatory bowel disease, ulcerative colitis, crohn’s disease, rheumatoid arthritis, inflammatory arthritis, and uveitis. sulfapyridine is used occasionally for dermatitis herpetiformis and related skin disorders when alternative treatment is unsuitable.Due to this drug interference, siemens will update the limitations of the procedure section of the instructions for use (ifu) for specific dimension and dimension vista assays.
  • Action
    Siemens is requesting that Customers: 1. Review this letter with their Medical Director; 2. Venipuncture should occur before drug administration of Sulfasalazine or Sulfapyridine as indicated under Reason/Issue. Baseline assay values before administration of Sulfasalazine or Sulfapyridine therapy would not be affected; 3. If any complaints of illness or adverse events are received associated with the specified products within the Customer Letter immediately contact your local Siemens Customer Care Centre or your local Siemens technical support representative; 4. Complete and return the Response Form by Friday 4th August 2017 as confirmation that you received and understood the bulletin; and 5. Retain the letter with your laboratory records, and forward the letter to those who may have received this product.

Device

Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical de...
  • Model / Serial
    Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD)Assays: Ammonia, Alanine Aminotransferase, Aspartate Aminotransferase, Glucose, Creatine Kinase MB and Thyroxine.Multiple Test Codes and Catalogue NumbersAll LotsARTG Numbers: 181689, 181688, 182776, 180109
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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