Events

Retiro De Equipo (Recall) de Cell Marque Rabbit Monoclonal Antibody. 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 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-2016-RN-01012-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-02
  • 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-01012-1
  • 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 has become aware certain lots of the rabbit monoclonal antibody exhibit an unacceptable immunohistochemistry (ihc ) test result. an investigation was undertaken which showed that lots 1335409a to 1335409f may exhibit a false negative result. false negative results are readily detected when appropriate tissue controls are used during testing. the manufacturer recommends the use of proper controls when performing ihc staining to detect this issue.
  • Acción
    Abacus ALS is advising users to destroy any remaining kits of the affected lots. Affected product will be replaced with unaffected kits or credit issued. This action has been closed-out on 02/03/2017.

Device

Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)Product Code: S100A1 (EP184)Affected products: Cell Marque S100A1 rabbit EP184 0.1 concentrate Catalogue Number: 408R-14Cell Marque S100A1 rabbit EP184 1 concentrateCatalogue Number: 408R-16Lot numbers: 1335409A to1335409FARTG Number: 239099
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd