Events

Retiro De Equipo (Recall) de Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical device

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-2018-RN-00023-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-09
  • 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-2018-RN-00023-1
  • 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
    An issue has been found with the stability of immunocap allergen c5, ampicilloyl and immunocap allergen c6, amoxicilloyl. an internal monitoring real time stability study determined that the stability specifications were not met. the products have a nominal 12 months shelf life stated on the label.The reduced stability may result in erroneous test results for affected lot numbers.No other immunocap tests are affected by this issue. no adverse events have been reported to date.
  • Acción
    Abacus is advising customers to discard any unused product. New product is expected to be available in Q3 2018. A review of previous results reported below the assay Limit of Quantification is advised.

Device

Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medi...
  • Modelo / Serial
    Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical deviceMaterial Numbers: 14-4450-01 and 14-4451-01Multiple Affected Lot NumbersARTG: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd