Events

Retiro De Equipo (Recall) de ACT 5DIFF SERIES HEMATOLOGY 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
    30894
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-06-21
  • 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 that the serial nameplate attached to rear of the affected devices does not include the nationally recognized testing laboratory (nrtl) certification graphic and therefore the affected devices do not meet the us and canadian occupational safety labeling requirements. this is a labeling error only as the safety of the product has been certified by the nrtl and otherwise meets the us and canadian occupational and safety requirements. the devices therefore are compliant with all ul/csa requirements and received the tuv certificates. the performance of the devices is not impacted.

Device

ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • Modelo / Serial
    Model Catalog: 6605641 (Lot serial: AV07017); Model Catalog: 175356 (Lot serial: AV12038); Model Catalog: 6605641 (Lot serial: AV12038); Model Catalog: 175356 (Lot serial: AV07017); Model Catalog: 175356 (Lot serial: AV05025); Model Catalog: 6605641 (Lot serial: AV14046); Model Catalog: 175356 (Lot serial: AV14046); Model Catalog: 6605641 (Lot serial: AV05025); Model Catalog: 6605641 (Lot serial: AV09024); Model Catalog: 175356 (Lot serial: AV09024)
  • Descripción del producto
    ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • 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