Events

Retiro De Equipo (Recall) de MAS OMNI IMMUNE LEVEL 2

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
    32379
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-10-03
  • 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 constituent inhibin a was removed from mas omni-immune and mas omni-immune pro controls however the package insert was not updated to reflect removal. the affected lots ahould not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.

Device

MAS OMNI IMMUNE LEVEL 2
  • Modelo / Serial
    Model Catalog: OIM-202 (Lot serial: OIM15092); Model Catalog: OIM-101 (Lot serial: OIM15091); Model Catalog: OPRO-202 (Lot serial: OPRO15102); Model Catalog: OPRO-SP (Lot serial: OPR1510S); Model Catalog: OPRO-303 (Lot serial: OPRO15103); Model Catalog: OIM-303 (Lot serial: OIM15093); Model Catalog: OPRO-101 (Lot serial: OPRO15101); Model Catalog: OIM-SP (Lot serial: OIM1509S)
  • Descripción del producto
    MAS OMNI IMMUNE LEVEL 2;MAS OMNI IMMUNE LEVEL 1;MAS OMNI IMMUNE PRO LEVEL 2;MAS OMNI IMMUNE PRO;MAS OMNI IMMUNE PRO LEVEL 3;MAS OMNI IMMUNE LEVEL 3;MAS OMNI IMMUNE PRO LEVEL 1;MAS OMNI IMMUNE
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD