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-2016-RN-01323-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-13
  • 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-2016-RN-01323-1
  • 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 shelf life of two lots of the albaclone advanced partial rhd typing kit has been reduced from 24 months to 12 months based on stability testing results for component l (anti-d cell line lhm57/17). the revised shelf life for each of these lots of kit has now expired and the kits are being recalled.
  • 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 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: Z293Affected Lot Numbers:V163020, expiry 11 Aug 2017V157640, expiry 9 Mar 2017ARTG Number: 225063
  • Manufacturer
    Haemokinesis Pty Ltd

Manufacturer

Haemokinesis Pty Ltd