Events

Rappel de Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00839-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00839-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA