Events

Retiro De Equipo (Recall) de Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)

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

¿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-2014-RN-00922-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-21
  • 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-2014-RN-00922-1
  • 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
    Siemens healthcare diagnostics has confirmed that when whole blood samples are run from small sample container (ssc – ks860 smn 10472099)), hba1c values may exhibit a percent bias ranging from -8.2% to +6.5% compared to results from the primary container. the percent bias range is a percentage of the hba1c result; it is not % hba1c units.
  • Acción
    Siemens Healthcare Diagnostics is advising customer not to use Small Sample Containers (SSC) when running whole blood samples with Dimension Vista HbA1c assay and to process HbA1c samples according to the Instructions For Use for Primary Tubes or Sample Cups i.e. samples should be mixed by inversion (gently invert the tube ten times) or in a rocker mixer to obtain uniform distribution of erythrocytes prior to testing. Users are also advised that the need for a look back at previously reported results should be discussed with the laboratories Medical Director.

Device

Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used ...
  • Modelo / Serial
    Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)Siemens Material Number (SMN): 10470481Catalogue Number: K3105AAll in-date lot numbers are affected ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA