Events

Retiro De Equipo (Recall) de OPTIVIEW AMPLIFICATION KIT

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

¿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
    23887
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-27
  • 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
    Related to customer complaint investigation a potential situation concerning dispenser issues with hematoxylin ii and horseradish peroxydase reagents where it was reported that these reagents dispensers could be leaking or sticking. this failure could result in a complete or partial dispense failure of a reagent critical to the staining reaction potentially leading to erroneous results.

Device

OPTIVIEW AMPLIFICATION KIT
  • Modelo / Serial
    Model Catalog: 760-099 (Lot serial: More than 10-contact manufact.); Model Catalog: 860-099 (Lot serial: More than 10-contact manufact.); Model Catalog: 790-2208 (Lot serial: More than 10-contact manufact.); Model Catalog: 605-100 (Lot serial: More than 10-contact manufact.); Model Catalog: 760-500 (Lot serial: More than 10-contact manufact.); Model Catalog: 800-098 (Lot serial: More than 10-contact manufact.); Model Catalog: 760-700 (Lot serial: More than 10-contact manufact.); Model Catalog: 760-091 (Lot serial: More than 10-contact manufact.)
  • Descripción del producto
    OPTIVIEW AMPLIFICATION KIT;HEMATOXYLIN II;CINTEC PLUS CYTOLOGY KIT;ULTRAVIEW UNIVERSAL DAB DETECTION KIT;ULTRAVIEW SISH DNP DETECTION KIT;OPTIVIEW DAB IHC DETECTION KIT;IVIEW DAB DETECTION KIT
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Dirección del fabricante
    LAVAL
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    HC