Events

Retiro De Equipo (Recall) de ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abacus ALS Pty 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
    RC-2016-RN-00014-2
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-01-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00014-2
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The ranges for mean concentration of igg/igg4 stated on the vial label of the quality control sample are incorrect. the new measuring ranges for immunocap specific igg/igg4 i1 control h, all lots when used in combination with immunocap i1, lot 389b7 and 389b8 are:igg4: 12 – 25 mg/ligg: 24 - 47 mg/lthe problem can be detected by the operator since the quality control samples will fail.
  • Acción
    The sponsor is advising users to use the following new measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H: IgG4: 12 – 25 mg/l IgG: 24 - 47 mg/l Patient results are not affected. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom.

Device

ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)
  • Modelo / Serial
    ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)Part Number: 10-9475-01Lot Numbers: All lot numbers when used in combination with ImmunoCAP Allergen i1Honey bee venom art. No 14-4143-01, lot numbers 389B7 and 389B8ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd