Events

Retiro De Equipo (Recall) de ImmunoCAP Allergen fx20, Food. 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-00222-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-02-21
  • 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-00222-1
  • 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
    Immunocap allergen fx20, food contains a mix of f4 (wheat), f5 (rye), f6 (barley), f9 (rice). due to a production non-conformity, certain lots of immunocap allergen fx20, food, may contain traces of oat (f7) allergen. this could cause false positive test results with regard to sensitisation to fx20 allergens for samples that are positive for oat allergen and negative for wheat, rye, barley, and rice allergens. however, this is an unlikely event because of the extensive cross-reactivity between the different cereal allergens and the low probability of monosensitisation to oat allergen in patients. therefore, it is unlikely that presence of oat allergen in immunocap allergen fx20 should result in incorrect test results for patient samples.
  • Acción
    Abacus ALS is advising users of the possibility of false positives with the assay due to the presence of oat allergen. ImmunoCAP whole allergens f4, f5, f6 and f9 can be used as an alternative for testing of patient samples.

Device

ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).Lot Numbers: AAS0D (exp 31 Mar 2012)AAS0E (exp 31 Mar 2013)AAS0F (exp 31 May 2014)AAS0G (exp 30 Nov 2014)AAS0H (exp 31 Jan 2015)AASG1 (exp 31 Jul 2016)AASG2 (exp 30 Jun 2016)AASG3 (exp 30 Jun 2018)ARTG Number:186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd