Events

Retiro De Equipo (Recall) de Dimension Vista Calcium (CA) Flex reagent cartridge. 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-2018-RN-00106-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-05
  • 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-2018-RN-00106-1
  • 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 affected dimension vista calcium (ca) flex reagent cartridge may produce erroneously low results from specific well sets. quality control (qc) may not detect the issue prior to patient testing if the ca calibration and qc are both processed in either an affected or unaffected well set.If ca reagent calibration is performed using an unaffected well set and qc and samples are subsequently processed using an affected well set, ca results may be falsely depressed, with observed biases from -0.075 mmol/l] to -0.7 mmol/l. if a ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. the observed bias for serum, plasma, and urine specimens are similar.
  • Acción
    Siemens Healthcare is advising users to discontinue use of, and discard the Dimension Vista Calcium Flex reagent lot 17171BD.

Device

Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: K1023Siemens Material Number: 10445160Lot Number: 17171BDARTG Number:181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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