Events

Retiro De Equipo (Recall) de UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

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
    22724
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-21
  • 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
    Beckman coulter has confirmed 5 issues on the unicel dxht 800 coulter cellular analysis system. issue 1: there is a possible dilution of sample if user requests a diluent dispense while specimens are being processed in cassette presentation resulting in erroneous results. issue 2: cbc: rbc and hct are improperly corrected and not flagged when there is a wbc pump error and the reported wbc > 140/ul. in body fluid (bf) panels: rbc is improperly corrected and not flagged when there is a wbc pump error. issue 3: there is a potential for erroneous retic results when the instrument user interface allows reflex processing of pre-diluted specimen in the retic test panel instead of limiting processing to cbc only. issue 4: there is the potential for body fluid results to be incorrectly interpreted by the laboratory information system. issue 5: sharp edges on the dxh800 reagent cabinet (floor stand) drawer slides may expose operators to physical injury while replacing reagents and waste containers.

Device

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Modelo / Serial
    Model Catalog: 629029 (Lot serial: ALL)
  • Descripción del producto
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • 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