Events

Retiro De Equipo (Recall) de Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. 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 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-2014-RN-00843-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-29
  • 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-2014-RN-00843-1
  • 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 a carry-over risk on sysmex cs systems due to the applications using ca-clean i (964-0631-3) for sample probe rinse. under certain circumstances, the carry-over might impact results for factor v with innovin, factor xii with dade actin fsl, berichrom f xiii, innovance d-dimer assays. in case of innovance d-dimer, only frozen samples are concerned by a potential carry-over. no impact by carry-over was observed with innovance d-dimer when using fresh normal plasma or control plasma.
  • Acción
    Siemens Healthcare Diagnostics is advising the user to run all affected above mentioned test applications (Protein C with Protein C Reagent, Protein S with Protein S Ac Reagent and Factor V Leiden with ProC Global Reagent) together in a “Batch Mode” and perform an extra prime and rinse step at the end of the batch. Siemens Healthcare Diagnostics is working on a solution to fix the issue and will communicate when a solution is available. Siemens does not recommend a look back of previously generated results since the coagulation status changes over the time, and does recommend that this communication is reviewed with the laboratory medical director.

Device

Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic me...
  • Modelo / Serial
    Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 10488064, 10488062, 10709128Affected Applications: Protein C with Protein C Reagent (OQYG11), Protein S with Protein S Ac Reagent (OPAP03) and Factor V Leiden with ProC Global Reagent (OQLS13)ARTG number:179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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