Events

Retiro De Equipo (Recall) de Liaison C-Peptid Assay. 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 DiaSorin Australia 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-00323-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-10
  • 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-00323-1
  • 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 recent testing of liaison c-peptid assay by diasorin has highlighted the issue of cross reactivity with human proinsulin. this cross reactivity occurs in 100% of the tested samples and results in an increased c-peptide concentration in all samples tested, across all populations. for normal patients, the risk of falsely elevated results is rare, since the concentration of proinsulin in healthy fasting people is at least 100 times lower than the c-peptide concentration and therefore has only minimal effect on the results determined with the assay. patient populations of highest risk for falsely apparently elevated assay results are patients with insulin processing defects, renal malfunction, insulinoma or similar conditions.
  • Acción
    DiaSorin is requesting users to confirm receipt of the “Urgent Recall for Product Correction” notification by completing the response section and returning it to DiaSorin. Users are advised of the possibility of further action pending TGA's receipt of additional information.

Device

Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD).Part Number: 316171All LotsARTG Number: 189435
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd