Events

Retiro De Equipo (Recall) de Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. 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 bioCSL 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-01146-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-24
  • 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-01146-1
  • 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
    This product is a 3 cell screening panel that is used in immunohematology testing to screen patient plasma or serum samples for the presence of clinically relevant red cell alloantibodies for pre transfusion and pre-natal testing.Cell 2 when tested against weak anti e controls (i.E. securacell) during pre-acceptance testing in biovue and grifols cat platforms, is giving weak or negative reactions and not the expected mid-strength reactions. however, testing in the bio-rad (diamed) cat platform is giving the expected result.There is a potential risk that undetected weak anti-e antibody using certain cat platforms could lead to delayed hemolytic transfusion reactions (dhtr) for the patient.
  • Acción
    The sponsor Seqirus is advising the users to inspect stock and quarantine all affected units prior to their return. The sponsor will arrange the replacement of the affected units or return credit. This action has been closed-out on 29/08/2016.

Device

Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)Abtectcell III% 0.8%Item Number: 22450201Lot Number: 2245204Expiry Date: 26/12/2015Abtectcell III% 0.8% Bulk PackItem Number: 22450205Lot Number: 2245204AExpiry Date: 26/12/2015ARTG Number: 223867
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd