Events

Retiro De Equipo (Recall) de Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).

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-2016-RN-01117-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-24
  • 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-2016-RN-01117-1
  • 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 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.
  • Acción
    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).
  • Modelo / 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
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA