Events

Retiro De Equipo (Recall) de EPICS XL/MCL ANALYZER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    28131
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2018-01-11
  • 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
    As a result of customer complaints and subsequent internal investigations beckman coulter has determined that an internal electronic component on the circuit "amplifier" boards in the epics xl/xl-mcl flow cytometry systems may be affected by a manufacturing defect. each epics xl/xl-mcl system contains up to seven (7) of the potentially affected amplifier boards. all instruments are potentially impacted.

Device

EPICS XL/MCL ANALYZER
  • Modelo / Serial
    Model Catalog: 626552 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6604988 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626554 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626551 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6605464 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 6605628 (Lot serial: ALL SOFTWARE VERSIONS); Model Catalog: 626553 (Lot serial: ALL SOFTWARE VERSIONS)
  • Descripción del producto
    EPICS XL/MCL ANALYZER;CYTOMICS FC 500 MPL (FLOW CYTOMETER) - INSTRUMENT;COULTER EPICS SERIES FLOW CYTOMETER SYSTEM - EPICS XL ANALYZER;CYTOMICS FC 500 FLOW CYTOMETER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC