Events

Retiro De Equipo (Recall) de ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD)

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 Healthcare Pty Ltd.

¿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-2016-RN-00180-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-22
  • 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-2016-RN-00180-1
  • 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 has confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. siemens’ internal investigation demonstrates:· an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42. · an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43. · the positive bias of lots ending in 42 to the master curve compared to the negative bias of lots ending in 43 to the master curve is the main driver for the negative bias between values generated with lots ending in 42 and 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the risk to health as a result of this issue is negligible. the biases observed across the assay range would not impact clinical management of patients being evaluated for androgen disorders or chemical castration.
  • Acción
    Siemens is advising users that Calibrator E with lots ending in 42 and 43 can continued to be used to calibrate Testosterone on the Centaur CP system. Lots ending in 44 and above should be used for other Centaur systems. A review of previously generated results due to this issue is at the discretion of the laboratory.

Device

ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An...
  • Modelo / Serial
    ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD)Catalogue Numbers: 04634452, 04634762, 04636889Siemens Material Number (SMN): 10309079, 10321075, 10335532Multiple Lot numbers affectedARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA