Events

Retiro De Equipo (Recall) de ALBAclone Advanced Partial RhD Typing Kit. 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 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-2017-RN-00628-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-25
  • 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-2017-RN-00628-1
  • 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 manufacturer has found that lot no v174693 has a reduced level of performance associated with components h and l, which are generating weaker than normal reactions with some weak rhd and partial rhd samples. reduced reactivity of components h and l is considered to make interpretation of the rhd variant sample type more difficult given results are available from only ten of the twelve monoclonal anti-d cell lines contained in the kit.
  • Acción
    Haemokinesis is advising users to quarantine and dispose of the affected lots. Haemokinesis will provide replacement stock or will issue a credit note. For previously generated results, the laboratory Medical Director should take into consideration the possible reduced reactivity of component H and L.

Device

ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: Z293Lot Number: V174693Expiry Date: 13 July 2017ARTG Number: 225063
  • Manufacturer
    Haemokinesis Pty Ltd

Manufacturer

Haemokinesis Pty Ltd