Events

Retiro De Equipo (Recall) de Epiclone Anti-M Blood Grouping Reagent. 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-01361-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-17
  • 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-01361-1
  • 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
    Seqirus has received notification that epiclone anti m lot 009817601 is showing false positive m reactions with m negative control cells in cat (column agglutination technology) biovue cards. investigational testing by seqirus suggests that there is an incompatibility between anti-m lot 009817601 and the cat biovue cards.
  • Acción
    Seqirus is advising customers to only use the product for phenotyping via the Tube method. Users should not continue use of the product with Column Agglutination Technology (CAT) Cards. Seqirus is advising laboratories to perform a review of previous positive reactions obtained where CAT Cards have been used with Epiclone Anti M Lot 00981760.

Device

Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)Product Item Number: 00980501Expiry: 11/06/2019Pack Size: 1 unit per packLot Number: 009817601ARTG: 225013 (Immunohaematology blood grouping
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd