Events

Retiro De Equipo (Recall) de Cortisol Saliva ELISA. 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-2018-RN-00109-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-07
  • 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-00109-1
  • 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
    The manufacturer, ibl has detected an issue that indicates a degradation in performance of the kit resulting in elevated cortisol values. when testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications; however, due to a degradation in the starting concentration of the calibration standards, the calculated results for individual patient samples may be higher compared to lc-ms/ms measurements and may trigger unnecessary additional testing.A review of additional data comparing the respective kit standards of the lots to lc-ms/ms data it is evident that the lots eco142 to eco143 generate elevated results:- eco142 (passing bablok fit (y=0.009988 + 1.549x)- eco143 (passing bablok fit (y=0.003142 + 1.623x)there has not been any reports of injuries associated with this issue.
  • Acción
    Abacus is advising users to inspect stock and quarantine any remaining stock of the affected batches. Affected product will be replaced with unaffected stock. A review of previously generated patient results is at the discretion of the Laboratory Director.

Device

Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)Catalogue Number: RE52611Lot Numbers: ECO142, ECO143Expiry Dates: ECO142: 2018-02-28; ECO143: 2018-12-31ARTG Number: 210636 (Abacus ALS - Clinical chemistry hormone IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd