Events

Retiro De Equipo (Recall) de ADVIA Centaur Systems Calibrator U (Myoglobin). 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-01056-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-10
  • 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-01056-1
  • 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 the advia centaur systems myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the advia centaur myoglobin instructions for use (ifu), for all in-date reagent lots when evaluated with calibrator u kit lots ending in 63 and 64. values up to 12 ng/ml (ug/l) were observed.Siemens’ investigation has identified that certain calibrator u kit lots have drifted from the internal standardisation causing a positive shift in results. analytical sensitivity and alignment to the internal standardisation will be restored with the release of calibrator u kit lots ending in 65 (cu65) and higher. customers will observe a negative shift in quality control (qc) material and patient results when transitioning to cu65. as a result, revised qc targets and ranges for bio-rad controls have been established and published on the bio-rad website at qcnet.Com.
  • Acción
    Siemens is advising that customers may continue to use Calibrator U lots CU63 and CU64 with any in-date reagent kit lot and current QC ranges. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the laboratory. Update 7 October 2016: Siemens are advising that Calibrator kit lot CU65 is now avaliable. The use of lots CU63 and CU63 should be discontinued and the lots discarded.

Device

ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)Test code: Cal UCatalogue Number: 03684480Siemens Material Number: 10309996Kit Lots ending in 63 (Expiry 03 Oct 2016) and 64 (Expiry 17 Jan 2017)ARTG Number: 175075
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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