Events

Retiro De Equipo (Recall) de Multiplate Analyser. 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 Haemoview Diagnostics.

¿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-00734-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-14
  • 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-00734-1
  • 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
    Roche identified that specific multiplate stirrer boards (replaced by another type 7.5 years ago) may develop an increasing stirring speed above specification. all channels are affected in the same way. too high stirrer speed may correlate with a falsely decreased recovery and therefore may lead to falsely low patient results. investigation has showed in maximum a reduced recovery of 80% (= bias -20%) and that the degree of decreased recovery depends on assay, with adp, trap, aspi more affected than col. although no testing was performed for the ristotest and adptest hs, similar low recovery of platelet function test results is assumed for these tests. in case of falsely low patient results due to falsely decreased recovery of platelet function tests (adptest, aspitest, traptest, coltest, ristotest adp hs test) the platelet function in diagnostic measures may be incorrectly interpreted as impaired.
  • Acción
    A Haemoview Diagnostics representative will schedule the necessary repair measures with the user. Until then, the affected Multiplate Analyser must not be used for diagnostic purposes. A loan device will be provided.

Device

Multiplate Analyser. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Multiplate Analyser. An in vitro diagnostic medical device (IVD)Product Code: 06675069001Serial Number: 100365ARTG Number: 263172
  • Manufacturer
    Haemoview Diagnostics

Manufacturer

Haemoview Diagnostics