Events

Retiro De Equipo (Recall) de Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-20 Automated Haematology Analysers)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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-01275-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-05
  • 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-01275-1
  • 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
    Sysmex has advised that specific lots of the fluorocell plt reagent may be susceptible to environmental factors causing a decrease in their fluorescence over time. in such instances, the affected lots could lead to a false low plt-f value, which will be inconsistent with the plt-i value.
  • Acción
    Roche is advising customers to discard any affected lots of Fluorocell PLT in use or stock. If available, users should use cartridges of an unaffected lot of Fluorocell PLT. Users should ensure that they perform reagent replenishment for Fluorocell PLT to flush out the old lot and completely replenish with unaffected reagent. If no other lot of Fluorocell PLT is available, please check PLT-F results for plausibility. If the PLT-F results are not plausible, please refer to the PLT-I results from the impedance channel. Users should follow internal SOP's regarding retrospective judgement of affected samples. Contact Roche Diagnostics Australia to discuss the need for replacement product.

Device

Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-2...
  • Modelo / Serial
    Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-20 Automated Haematology Analysers)Fluorocell PLT 2 x 12 mLLot Numbers: A6051 to A6090ARTG Number: 188498
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited