Events

Retiro De Equipo (Recall) de MAS CARDIOIMMUNE XL MULTI-PACK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DIAGNOSTIX LTD.

¿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
    43343
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-12-20
  • 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
    Troponin i results in the cardioimmune xl control are measuring approximately 15-30% low in levels 1 and 3 resulting in control measurements which are outside the published value assignment ranges. as a precaution we are proactively recalling all levels associated with lot cxl1301. only troponin i control measurements are affected all other control analyte measurements are recovering within the published value assignment ranges. we are currently investigating the root cause.

Device

MAS CARDIOIMMUNE XL MULTI-PACK
  • Modelo / Serial
    Model Catalog: CAI-XL4 (Lot serial: CXL13014); Model Catalog: CAI-XL2 (Lot serial: CXL13013); Model Catalog: CAI-XL1 (Lot serial: CXL13013); Model Catalog: CAI-XL3 (Lot serial: CXL13012); Model Catalog: CAI-XL2 (Lot serial: CXL13012); Model Catalog: CAI-XL3 (Lot serial: CXL13011); Model Catalog: CAI-XL2 (Lot serial: CXL13011); Model Catalog: CAI-XL1 (Lot serial: CXL13011); Model Catalog: CAI-XL3 (Lot serial: CXL13013); Model Catalog: CAI-XL1 (Lot serial: CXL13012); Model Catalog: CAI-XLL (Lot serial: CXL1301L)
  • Descripción del producto
    MAS CARDIOIMMUNE XL MULTI-PACK
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD