Events

Retiro De Equipo (Recall) de ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device.

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 Ltd Diagnostics Division.

¿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-00062-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-28
  • 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-00062-1
  • 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 incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i, lot 3jd018, for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays. this issue was determined to be the result of calibrator value miscalculation. calibrator lot 3jd018 has now been value assigned to align with the correct calibrator values.This poses a risk of an incorrect value of -10% being assigned for phenytoin testing and 3% for phenobarbital.Siemens considers these differences are negligible and would not be considered substantially relevant to impact clinical care in practice.
  • Acción
    Calibrator value reassignments are being provided in the Customer Letter for users to correct the problem. This action has been closed-out on 14/02/2017.

Device

ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro...
  • Modelo / Serial
    ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device. Lot Number: 3JD018Expiration Date: April 2015Siemens Material Number: 10376770ARTG Number: 175699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA