Events

Retiro De Equipo (Recall) de Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)

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-2012-RN-01135-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-08
  • 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-2012-RN-01135-1
  • 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
    The operating range of the advia centaur systems is 18°c to 30°c. the affected assays can product inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.This phenomenon is observed when assay results are reported at a temperature different from the temperature at which the assay was calibrated. depending on the frequency of quality control testing and laboratory temperature at the time quality controls are tested, this issue may not always be detected through routine quality control monitoring.
  • Acción
    Customers are being advised to immediately implement the revised room temperature operating ranges for the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP assays

Device

Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline...
  • Modelo / Serial
    Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)Theophylline 2ARTG: 175699Procalcitonin, DHEA-SO4ARTG: 175698FolateARTG: 175700BR Assay for CA 15-3, CA 19-9, BR Assay for CA 27.29ARTG: 175636BNPARTG: 175075Multiple SN and REF Numbers
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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