Events

Retiro De Equipo (Recall) de VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

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
    114189
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-11
  • 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
    Ortho clinical diagnostics (ortho) has initiated this recall due to a vitros system software timing anomaly that could cause two different sample metering scenarios that may lead to erroneous results. scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) causing sample b to be contaminated and diluted by sample a.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 680 2413 (Lot serial: 36000264); Model Catalog: 680 2413 (Lot serial: 36000773); Model Catalog: 680 2413 (Lot serial: 36000627); Model Catalog: 680 2413 (Lot serial: >10 serial numbers affected); Model Catalog: 680 2783 (Lot serial: >10 serial numbers affected); Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); Model Catalog: 680 2783 (Lot serial: 36000773)
  • Descripción del producto
    VITROS 5600 Integrated System;VITROS 3600 Immunodiagnostics System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS