Events

Retiro De Equipo (Recall) de Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMP

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-00961-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-25
  • 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-00961-1
  • 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
    The reagent kit lots listed above demonstrate an increased incidence of absorbance flags (u, u) and //// errors. absorbance flags u and u indicate abnormal high absorbance exceeding either the blank or sample limit. absorbance flag //// indicates a calculation error and no result is generated by the system.The increased rate of absorbance flags with these lots has not been associated with inaccurate results. if calibration and quality control results are acceptable, reported patient results are acceptable. this risk to health is negligible. siemens advises the potential for clinical impact and overall risk to health as a result of this issue is negligible.
  • Acción
    Customers are asked to quarantine affected units from use prior to destruction and/or disposal.

Device

Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XP...
  • Modelo / Serial
    Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMPCatalogue Number: 03035814Lot Number: 327460Alkaline Phosphatase ALPDEACatalogue Number: 03036535Lot Number: 327465 Alkaline Phosphatase Concentrated ALPA_cCatalogue Number: 06860450Lot Number: 327471ARTG Number: 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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