Events

Retiro De Equipo (Recall) de Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (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-2013-RN-00171-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-22
  • 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-2013-RN-00171-1
  • 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 has confirmed complaints of low qc and patient recovery with the dimension vista® loci digoxin (digxn) flex® reagent cartridge when calibrating digxn with either drug 4 cal (kc460) lot 2kd052 or drug 4 cal (kc460a) lot 2kd053. internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/ml.
  • Acción
    Customers are requested to immediately discard any remaining stock. Siemens is asking customers to discuss the issues with the laboratory director so that they can determine if additional follow-up is required for patient tests conducted with the affected lots.

Device

Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagno...
  • Modelo / Serial
    Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (IVD).Vista Drug 4 CalibratorCatalogue number: KC460 Siemens material number: 10472284Lot number: 2KD052 Vista Drug 4 Calibrator Lot (SMN ) Catalogue number: KC460A Siemens material number: 10476171Lot number: 2KD053 ARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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