Events

Retiro De Equipo (Recall) de Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. 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 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-2013-RN-00170-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-22
  • 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-2013-RN-00170-1
  • 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 recent investigations, siemens healthcare diagnostics has observed that the affected lot numbers show an increase in heparin sensitivity over the shelf life, prolonging activated partial pro thromboplastin times (aptt). this issue is demonstrated by testing with dade® citrol® heparin control, low and high.
  • Acción
    Siemens is requesting customers to discontinue the use of the affected lots and discard any remaining inventory of the affected lots. A look back of previously reported Dade Actin FSL APTT results is at the discretion of the laboratory.

Device

Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical d...
  • Modelo / Serial
    Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical device (IVD).Lot 547311 (Cat. no. B4219-1 / SMN 10445713)Lot 547312 (Cat. no. B4219-2 / SMN 10445714)Lot 547316 (Cat. no. B4219-2J / SMN 10465681)Lot 547316A (Cat. no. B4219-2 / SMN 10445714)Lot 547316AA (Cat. no. B4219-2J / SMN 10465681)ARTG Number: 178501
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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