Events

Retiro De Equipo (Recall) de Leica Bond Ready-to-Use RNA Negative Control Probe

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
    19682
  • Fecha de inicio del evento
    2016-01-20
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Leica Microsystems Pty Ltd, New Zealand Branch, 3/33 Spartan Road, Takanini, Auckland 2105
  • Causa
    Manufacturer recently became aware that the product / detection kit combinations identified above may not provide adequate staining when used according to the ifnstructions for use (ifu). if the products are used according to their ifu 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., bond polymer refine detection kits are intended for use with a large numberof other products and the identified kit lots function as specified except when used with the antibody and probe product codes listed in the table above.
  • Acción
    Product to be returned to supplier

Device

Leica Bond Ready-to-Use RNA Negative Control Probe

Manufacturer

manufacturer #1479