Events

Retiro De Equipo (Recall) de Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices

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-2018-RN-00002-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-12
  • 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-00002-1
  • 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 diagnostics have been made aware of issues regarding leaking and sticking reagent dispensers that may lead to the incomplete dispensing of a reagent required for the staining reaction. this in turn could result in light or absent staining, which without any mitigations, could cause a delay or an error in diagnosis.
  • Acción
    The manufacturer is producing new lots and customers will be notified when corrected product is available. In the interim, affected kits may continue to be used by customers but the affected kits must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results. For assays that directly relate to clinical therapy decision making, it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative.

Device

Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices
  • Modelo / Serial
    Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devicesOptiView DAB IHC Detection Kit Marial Number 06396500001Lot Number Y11625, Y15571, Y19271ultraView DAB IHC Detection KitMaterial Number 05269806001Lot Number Y09284, Y15384OptiView Amplification Kit Material Number 06396518001Lot Numbers: Y15435, Y19322Hematoxylin IIMaterial Number 05277965001Lot Numbers: Y10759, Y13938, Y17402, Y17403, Y21312, Y22561ARTG 174896 and 174922
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited