Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL 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
    52233
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-06-10
  • 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
    Ocd has announced a recall to inform customers of a change to the frequency of replacement for the cm/rt wear pads on vitros 5600 4600 and 51 fs systems. cm/rt wear pads are a component in the cm/rt incubator. the cm/rt rotor revolves on three wear pads within the incubator. by design there is a small gap between the rotor and the hot plate to allow for the transfer of heat. if the wear pads become too thin it may cause the rotor to rub on the hot plate resulting in black dust within the incubator. the impact of black dust may contribute to unplanned system down time. we have no data that suggests that black dust has any adverse effect on results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Modelo / Serial
    Model Catalog: 6801375 (Lot serial: > 10 contact manufacturer); Model Catalog: 6802413 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801890 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2445 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    VITROS 51 FS Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS