Events

Retiro De Equipo (Recall) de Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. 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 Leica Microsystems 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-00069-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-18
  • 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-00069-1
  • 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
    Leica biosystems recently became aware that the product / detection kit combinations identified may not provide adequate staining when used according to the instructions for use. if the products are used according to their instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
  • Acción
    Leica Biosystems is advising users to discontinue use of the listed antibodies / probes with the specified detection kits. There are alternative kits available for use. Leica is advising that there is no requirement for a review of previously reported results if appropriate positive controls were used.

Device

Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An...
  • Modelo / Serial
    Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An in vitro diagnostic medical device (IVD)Multiple antibody and probes affectedProduct Codes: PA0552,PA0210,PB0614,PB0589,PB0645,PB0669,PB0809,PB0785All lot numbers affectedAffected Bond Polymer Refine Detection KitsProduct Code: DS9800Lot Numbers: 42314,42388,42474,42486,42499,42555,42570,42579,42627,42645,42683,42780,42802,42823,42852,43050Expiry Dates: 02 April 2017 to 21 May 2017
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd