Events

Retiro De Equipo (Recall) de Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). 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-01084-1
  • 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-01084-1
  • 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 determined that dimension vista mass ckmb isoenzyme calibrator (mmb cal) shows drift during routine stability monitoring that exceeds siemens acceptance criteria for drift over the shelf life of this product. siemens has observed drift from 3% to 12% at mmb concentrations across the assay range. depending on quality control limits, this drift may not have been detected. due to the drift, siemens is revising the expiration date of this product. the manufacturer has confirmed routine stability monitoring data for mmb cal only supports six months. product is labelled for 12 months.
  • Acción
    Siemens Healthcare Diagnostics is requesting the customers to discard any remaining inventory of MMB CAL lots and to recalibrate with lot 4FD073 on next calibration. Review of previous testing is at discretion of the laboratory. This action has been closed-out on 04/04/2017.

Device

Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical ...
  • Modelo / Serial
    Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10445195Test Code: 0317Catalogue Number: KC672Lot Numbers: 3JD045,4BD064, 4CD012, 4DD065ARTG Number 182776
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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