Events

Retiro De Equipo (Recall) de ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (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-01080-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-08
  • 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-01080-1
  • 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 there may be an incorrect side label on a small percentage of the advia centaur systems bnp ready packs from reagent lot 038174. incorrectly labelled ready packs are included within kit lots 43305174, 43278174, 43306174 and 43279174. the human-readable side label may incorrectly identify the ready pack as advia centaur systems ft4 ready pack. the ready pack end label and the barcode end label correctly identify the ready pack as the advia centaur systems bnp ready pack and the ready pack will scan correctly as bnp when loaded onto the advia centaur systems. the kit boxes are correctly labelled as bnp. other advia centaur bnp kit lots ending in 174 are not impacted. the reagent in the ready pack has been verified as bnp reagent and will generate valid results when calibrating and running quality control or patient samples using the affected advia centaur systems bnp ready pack kit lots.
  • Acción
    Siemens Healthcare Diagnostics(SHD) is instructing their customers to examine their inventory of BNP Ready Packs identified with the human-readable FT4 side labels and discard any affected packs. Siemens representative will provide the product replacement. Siemens is also informing their customers that any results generated with an affected pack are valid; the instruments identify the pack correctly and there is no performance issue with the reagent within the packs. This action has been closed-out on 11/08/2016.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro dia...
  • Modelo / Serial
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro diagnostic medical device (IVD))Catalog Number: 02816138 Siemens Material Numbers: 10309044 Kit Lots: 43305174, 43278174Catalog Number: 02816634 Siemens Material Numbers:10309045 Kit Lots:43306174, 43279174Expiration Date: July 11, 2015 ARTG number: 175075
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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