Events

Retiro De Equipo (Recall) de ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. 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-00310-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-13
  • 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-00310-1
  • 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 platelet clump flags (plt-clm) are generated in the perox channel of the advia 120/2120/2120i haematology system while running cbc/diff (complete blood count / differential) whole blood samples with diff timepac perox 1 reagent lot # 57211, in samples without platelet clumps. the accuracy of the platelet results are not impacted when the perox 1 reagent (lot 57211) is used on the system and a plt-clm flag is generated due to this issue. additionally, platelet results are reported from the red blood cell/platelet (rbc/plt) channel and not measured in the perox channel where platelet clumps are detected. however, the platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.
  • Acción
    Siemens is requesting customers discontinue use of and discard the entire lot of ADVIA 120/2120/2120i DIFF TIMEPAC products listed in Table 1 of the Customer Letter. Complete and return the Response Form attached to the Customer Letter by Friday 20th April 2018 as confirmation that you have received and understood this Recall Action.

Device

ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Med...
  • Modelo / Serial
    ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Medical Device (IVD)Catalogue Number: SMN 10312270Lot Numbers: 74264,73839, 57211Expiration Date: 31/7/19 ARTG Number: 184207(Siemens Healthcare - Haematology full blood count IVDs)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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