Events

Retiro De Equipo (Recall) de VITROS 4600 CHEMISTRY SYSTEM - HARDWARE

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
    52191
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-23
  • 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 inc. (ortho) initiated this urgent product correction notification due to the need to clarify operator actions following u90-382 or 6lu condition codes generated by the systems affected by this recall. u90-382 or 6lu condition codes are associated with wash errors that may occur when using vitros chemistry products for immunorate assays (i.E. vitros crbm crp dgxn and phyt slides). if a u90-382 or 6lu condition code (i.E. associated with a wash error) occurs the condition code text located on the vitros system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios.

Device

VITROS 4600 CHEMISTRY SYSTEM - HARDWARE
  • Modelo / Serial
    Model Catalog: 680 2445 (Lot serial: >10 contact manufacturer); Model Catalog: 680 2153 (Lot serial: >10 contact manufacturer); Model Catalog: 680 1375 (Lot serial: >10 contact manufacturer); Model Catalog: 680 1759 (Lot serial: >10 contact manufacturer); Model Catalog: 813 2086 (Lot serial: >10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: >10 contact manufacturer)
  • Descripción del producto
    VITROS 4600 Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS