Retiro De Equipo (Recall) de ALBAclone Anti-Leb, (LEB2) 1 x 5mL(Immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Haemokinesis 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-00898-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-18
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Potential patient risk:-performance issues have been identified during internal use of the reagent. it has been determined that there is a potential for weak or false negative results with some leb positive blood cells.
  • Acción
    Affected units are being recalled from the market. This action has been closed-out on 20/06/2016.

Device

  • Modelo / Serial
    ALBAclone Anti-Leb, (LEB2) 1 x 5mL(Immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.)Product Code: Z217Lot Number : V158461ARTG Number: 225063
  • Manufacturer

Manufacturer