Events

Retiro De Equipo (Recall) de CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate and CD7 Mouse Monoclonal Antibody (MRQ-12) 0.5ml concentrate (T-cell markers used in immunohistochemistry). An in vitro diagnostic medical device (IVD)CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abacus ALS 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-2012-RN-01063-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-24
  • 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-2012-RN-01063-1
  • 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
    Cell marque corporation recently became aware that one lot labelled as cd7 is actually cd2 (cd2 and cd7 are markers for t-cells and nk-cells).
  • Acción
    Quarantine and dispose of any remaining affected product appropriately.

Device

CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate and CD7 Mouse Monoclonal Antibody (MRQ-12)...
  • Modelo / Serial
    CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate and CD7 Mouse Monoclonal Antibody (MRQ-12) 0.5ml concentrate (T-cell markers used in immunohistochemistry). An in vitro diagnostic medical device (IVD)CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrateLot Number: 8109Catalogue Number: 107M-16CD7 Mouse Monoclonal Antibody (MRQ-12) 0.5ml concentrateLot Number: 8109Catalogue Number: 107M-15
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd