Events

Retiro De Equipo (Recall) de RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 tests

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-00855-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-09-04
  • 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-00855-1
  • 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
    During the manufacturing process, the sodium high calibrator value was incorrectly assigned for the rapidpoint 500 measurement cartridge causing a negative bias on both qc and patient samples.This issue causes a varying negative bias across the measurement range, with the bias increasing with increasing sodium concentrations. taking into account the magnitude of the bias near the reference interval, this issue is not expected to cause clinically significant changes to patient treatment decisions for hypernatremia.
  • Acción
    Siemens is notifying laboratories of the error and that the review of previously generated results is at the discretion of the laboratory. Laboratories are given the option to return the affected products. This action has been closed-out on 07/09/2016.

Device

RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic m...
  • Modelo / Serial
    RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 testsSerial Numbers affected: 2517102517 through 2519000012.Please note: Cartridges within the affected serial number range that have a green dot on the box and/or the cartridge are not affected.ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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