Events

Retiro De Equipo (Recall) de EliA Intrinsic Factor Well. 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 dx 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-00317-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-11
  • 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-00317-1
  • 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
    A malfunction of elia intrinsic factor well has been discovered in elia intrinsic factor well lot 0015. a customer complaint reported erroneous test results on one single carrier of elia intrinsic factor well (14-5668-01) lot 0015. internal investigation by phadia ab indicated that no antigen solution was dispensed during elia well coating for a part of the lot. the described problem could cause erroneous test results. an erroneous test result means that the reported value will be lower than the real value for the patient sample tested, causing false negative results.To date, there have been no reports of patient injury as a result of this issue. no other lots of elia intrinsic factor well are affected.
  • Acción
    Abacus is advising customers to inspect stock immediately and quarantine any stock of Lot # 0015 to prevent further use. Customers should record the quantity in quarantine on the Customer Reply Form provided with the Customer Letter. Once the form is returned, Abacus will provide users with instructions to destroy or return the quarantined product.

Device

EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)Catalogue Number: PU14566801Lot number: 0015Expiry date: 31/01/2019ARTG: 229585Abacus dx - Clinical chemistry autoimmune IVDs
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd