Retiro De Equipo (Recall) de IRT Screening Assay used for screening newborns for cystic fibrosis. 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    For two lots of the irt screening assay kit (e-kr-480) there is a computer transcription error in the qc sheets for the value of standard 3, where the value is 50 µg/l instead of 60 µg/l. it has been determined via internal testing that if the cut-off value in use by the laboratory is 90 µg/l or higher, there is no risk of false positive results. for a cut-off value lower than 90 µg/l, the clinical impact depends on the cut-off value fixed by the laboratory/physician. so, depending on the cut-off value used, there may be a risk of a false positive result. as the irt screening assay is a screening test, all positive must be retested using a confirmatory method. thus, false positive patients will be retested with other tests (dna etc.) and found negative without harming the health of the patient being a false positive.
  • Acción
    Abacus ALS is advising users that the correct value of Standard 3 is 50ug/mL (rather than 60ug/mL). The customer letter should be discussed with the Medical Director, with consideration given to the need for a look-back of results previously generated using the affected lots. This action has been closed-out on 01/03/2018.


  • Modelo / Serial
    IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).Reference Number: E-KR-480Lot Numbers: 013A & 016AARTG Number: 274979
  • Manufacturer