Events

Retiro De Equipo (Recall) de BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA MICROSYSTEMS INC..

¿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
    69955
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    These antibodies and probes when used in combination with specified lots of the bond polymer refine detection and novolink polymer detection system 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.

Device

BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)
  • Modelo / Serial
    Model Catalog: PA0210 (Lot serial: all lots); Model Catalog: PB0645 (Lot serial: all lots); Model Catalog: PB0669 (Lot serial: all lots); Model Catalog: PB0785 (Lot serial: all lots); Model Catalog: PA0552 (Lot serial: all lots); Model Catalog: PB0614 (Lot serial: all lots); Model Catalog: PB0809 (Lot serial: all lots); Model Catalog: PB0589 (Lot serial: all lots); Model Catalog: NCL-L-AMACR (Lot serial: all lots)
  • Descripción del producto
    BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMU1)
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.
  • Dirección del fabricante
    BUFFALO GROVE
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC