Events

Retiro De Equipo (Recall) de 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-2013-RN-00315-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-09
  • 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-2013-RN-00315-1
  • 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
    Issue 1 - siemens healthcare diagnostics have confirmed a positive bias for values below 6%, there is a positive bias of 0.3% with an upper 95% confidence interval of 0.7%.Issue 2 - siemens healthcare diagnostics have confirmed a higher frequency of "above assay range" flags. there is a higher frequency of flags is related to higher recoveries of sample haemoglobin (hb) values (hb >25g/dl or >15.5mmol/l). the hb value is used to calculate the final output hba1c ratio (% hba1c [mmol/mol] result. results are suppressed (not reported) with the "above assay range" flag.
  • Acción
    Customers should immediately discard any remaining inventory of the affected lots of Dimension Vista® HbA1c (K3105A). Siemens will replace any unused inventory of the affected lots at no charge. Siemens is recommending customers to discuss the issues with their Medical Director to determine if additional follow up is appropriate for patient tests conducted with the lots affected.

Device

HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vis...
  • Modelo / Serial
    HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)Catalogue Number: K3105ASiemens Material Number (SMN): 10470481Lot numbers: 12072AA, 12086AA, 12107AA, 12128AA, 12150AA, 12191AA, 12212AA, 12226AA, 12248AA, 12261AA, 12282AA, 12303AAARTG: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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