Events

Retiro De Equipo (Recall) de Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. 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-01393-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-06
  • 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-01393-1
  • 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 previously confirmed that when whole blood samples are run from the small sample container (ssc), the hba1c value may contain a percent bias range of - 8.2% to + 6.5% (tga ref: rc-2014-rn-00922-1). due to this bias, use of the ssc was withdrawn. as a follow up siemens healthcare diagnostics has confirmed that the ssc can now be used with the dimension vista haemoglobin a1c (hba1c) assay with software version 3.6.2 or higher. the hba1c instructions for use beginning with lot 17205ba will detail use of the ssc.
  • Acción
    Siemens is advising users that samples for the HbA1c method can be assayed from a Small Sample Container (SSC) loaded in a “Surplus” sample rack and processed as Routine or STAT. When using an SSC, pipette a minimum of 400 uL of the whole blood sample and load in a “Surplus” sample rack using a 13mm tube insert (Do not run from a “Limited” sample rack).

Device

Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3....
  • Modelo / Serial
    Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. An in vitro diagnostic medical device (IVD)Assay: Dimension Vista HbA1CCatalogue Number: K3105ASiemens Material Number: 10470481ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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