Events

Retiro De Equipo (Recall) de UNICEL DXI 800 ACCESS IMMUNOASSAY 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 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
    56429
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-01-28
  • 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
    The sample presentation unit ("spu") may push two sample racks instead of one into the sample presentation area when the gap between racks is obstructed with foreign material such as tape. beckman coulter has received a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. the first rack of the two was not scanned. this is referred to as a "pushed pair.".

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - ANALYZER - CLASS II
  • Modelo / Serial
    Model Catalog: 973100 (Lot serial: 973100); Model Catalog: 4773 (Lot serial: A64935); Model Catalog: 4771 (Lot serial: A64871); Model Catalog: A30260 (Lot serial: A30260); Model Catalog: A71461 (Lot serial: A71461); Model Catalog: 4768 (Lot serial: A59102)
  • Descripción del producto
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS II
  • 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