Events

Retiro De Equipo (Recall) de ENGEN AUTOMATED SAMPLE HANDLING SYSTEM

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
    101180
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-09-08
  • 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 pertaining to engen systems configured with a thermo scientific centrifuge module and tcautomation (tca) software versions 3.6.1 and below. ortho became aware of one confirmed instance of test results that were mis-associated with the wrong sample id (sid) and were reported prior to the engen system detecting the sid mismatch. assay results are potentially associated with the wrong patient and reported out of the laboratory. this could lead to inappropriate intervention with the potential for serious injury to the patient. ortho received no reports of patient injury due to this issue.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Modelo / Serial
    Model Catalog: ENGEN (Lot serial: JCT20Q3J); Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: J41BCY4J); Model Catalog: ENGEN (Lot serial: J953244)
  • Descripción del producto
    enGen Laboratory Automation System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS