Events

Retiro De Equipo (Recall) de Randox Lipase Reagents for use on RX instruments. 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 Randox 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-2018-RN-00239-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-29
  • 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-00239-1
  • 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
    Randox have identified that the reagent triglycerides can cause elevated lipase results when the lipase reagent is run after triglycerides within the same run. this can affect a qc or patient sample test result. randox have now released further steps for contamination avoidance with the lipase assay on rx instruments. users should refer to the instrument testing order specifically arranging chemistries so that lipase and triglycerides are the last two chemistries in the test running order.In the event of an extremely elevated lipase result, cuvette maintenance steps should be performed as recommended for each rx system. the sample should then be re-tested running the lipase assay in isolation.
  • Acción
    Randox is advising customers and distributors to amend their test running order and update the RX analyser operator manual with the revised information. Updated IFU's will be provided to users. In the event of an extremely elevated Lipase result, cuvette maintenance steps should be performed as recommended for each RX system. The sample should then be re-tested running the Lipase assay in isolation.

Device

Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)Catalogue Numbers: LI7979, LI8050ARTG Number: 199615(Randox Australia - Clinical chemistry enzyme IVDs)
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA