Events

Retiro De Equipo (Recall) de ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical 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-2017-RN-00912-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-02
  • 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-2017-RN-00912-1
  • 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
    Abacus als is advising that immunocap allergen f205, herring, lot 999g5 contains the wrong allergen. this could cause erroneous test results, which may cause a delay in a proper diagnosis, however, the probability of a serious adverse health consequence or serious deterioration in state of health due to a delayed diagnosis is estimated to be negligible.
  • Acción
    Actions to be taken by the customer/user: 1. Stop using the affected lots; 2. Discard any unused product; 3. Retest any samples that have been tested using the affected product; and 4. Fill in the Medical Device Recall return response form supplied with the customer letter and return to Abacus ALS.

Device

ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)Product Number: 14-4837-01Lot Number: 999G5ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd