Events

Retiro De Equipo (Recall) de Panocell-20 and Capture-R Ready-ID. 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 Seqirus 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-00305-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-03-03
  • 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-00305-1
  • 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, immucor has identified issues with panocell-20 and capture-r ready-id.For panocell-20, donor e1011 was listed as v+ (positive) on the master list supplied with this product. the donor has subsequently been tested as v - (negative). since donor e1011 is v–, cell number 11 will be nonreactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system. for capture-r ready-id, donor d1741 was listed as v+ (positive) on the master list supplied with this product. dna testing of this donor has confirmed the donor as v - (negative). since donor d1741 is v–, cell number 4 will be non-reactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system.
  • Acción
    Seqirus is providing revised master lists for the affected products which correctly identify the donors as V- (negative). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 05/07/2017.

Device

Panocell-20 and Capture-R Ready-ID. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Panocell-20 and Capture-R Ready-ID. An in vitro diagnostic medical device (IVD).Panocell-20Item Number: 5020Lot Number: 52872Cell Number: Cell #11Expiry: 3 March 2017Capture-R Ready-IDItem Number: 66214Lot Number: ID324Cell Number: Cell #4Expiry: 2 May 2017ARTG Number: 245555ARTG Number: 245555
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd