Events

Retiro De Equipo (Recall) de ADVIA Chemistry Products - Ammonia, Salicylate and Alanine Aminotransferase Assays. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00837-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-06
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00837-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.It has been confirmed that falsely depressed or falsely elevated results may occur on samples drawn from patients taking sulfasalazine and sulfapyridine as 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.
  • Acción
    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

ADVIA Chemistry Products - Ammonia, Salicylate and Alanine Aminotransferase Assays. An in vitro d...
  • Modelo / Serial
    ADVIA Chemistry Products - Ammonia, Salicylate and Alanine Aminotransferase Assays. An in vitro diagnostic medical device (IVD)Multiple Test Codes and Reference NumbersAll Lot NumbersARTG Numbers: 176642, 176646, 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA