Events

Retiro De Equipo (Recall) de Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). 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-00063-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-12
  • 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-00063-1
  • 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
    Some lots of the crag lfa have been found to have reduced specificity (90% now versus 99% before). the health risk only applies to patients with positive test results. a small number of samples with positive test results may not be true positives, which may cause some patients to initiate unnecessary anti-fungal therapy. samples with negative test results are not affected. the negative predictive value remains high at nearly 100%. there have been two customer complaints associated with this problem. there have been no reports of patient injury or death.
  • Acción
    Abacus ALS is advising users to destroy stock from the affected lots to prevent further use. Replacement stock will be provided. Customers may decide to retest samples previously reported as positive using affected lots. Abacus ALS will provide replacement tests to perform retesting if this is required. This action has been closed-out on 01/03/2018.

Device

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).Kit Item Number: CR2003Lot Numbers: 161019161504NZ & 161007110553JGARTG Number: 272537
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd