Events

Retiro De Equipo (Recall) de Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). 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-01374-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-18
  • 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-01374-1
  • 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 has confirmed that for several lots the currently assigned dbil_2 assigned calibrator values (acvs) may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. quality control (qc) material is also affected by this issue. depending on the quality control concentrations and ranges used by the laboratory, quality control may not detect this issue. the positive bias may lead to an overestimation of direct bilirubin and the potential for further monitoring or confirmation of a potentially abnormal direct bilirubin finding during the assessment of liver dysfunction and/or during the investigation of jaundice. to correct the positive bias and restore alignment to the reference method, the acv for dbil_2 has been reassigned from 77 micromol/l to 55 micromol/l. all other analytes present in the chemistry calibrator meet product standards.
  • Acción
    Siemens is advising users to use the reassigned DBIL_2 ACVs for the affected Chemistry Calibrator lot numbers. In addition, laboratories should review the targets and ranges for quality controls used with the DBIL_2.

Device

Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vit...
  • Modelo / Serial
    Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD).ADVIA Chemistry CalibratorSiemens Material Number (SMN): 10312279 Lot Numbers: 680726 (exp. 2017-06), 680726A (exp. 2017-09), 680726B (exp. 2017-09), 680726C (exp. 2018-02), 680726D (exp. 2018-02)ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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