Events

Retiro De Equipo (Recall) de 96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)

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-2015-RN-01257-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-22
  • 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-2015-RN-01257-1
  • 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 is providing this communication to customers regarding a defect observed in the deep well plate used on the versant kpcr sample preparation and tissue preparation systems. multiple plates in lot 143449 have been observed to have extraneous plastic in the interior of the well at position f7 of the plate. if present, this extraneous plastic may cause a jam of the 1 ml pipet tip during dispense of reagent. the jamming of the pipet tip may result in a failure of the run. this failure will prevent the reporting of any patient results from that run and the samples must be repeated.
  • Acción
    Siemens is advising users to inspect stock and to discontinue use and discard any of the affected lot. Siemens is advising users that the review of previous patient data is at the discretion of the Laboratory Director. This action has been closed-out on 17/05/2017.

Device

96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)
  • Modelo / Serial
    96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)Siemens Material Number: 10283255Lot Number: 143449ARTG Number: 175890An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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