Events

Retiro De Equipo (Recall) de AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). 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 Zoll Medical Australia 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-2016-RN-01265-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-29
  • 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-2016-RN-01265-1
  • 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
    It has been determined that a limited number of avoxmeter 1000e cuvettes have exceeded internal control limits for gap measurement. the gap measurement is incorporated into the pathlength value, which in turn is entered into the settings of avoximeter instruments when a new lot of cuvettes are used to run a test. the pathlength values add an additional degree of accuracy in the total haemoglobin (thb) reported value and those calculations where thb is used as a variable. the pathlength values do not affect %02hb, %cohb or %methb results.The affected avoximeter cuvettes may have a slight upward shift in pathlength that can result in a clinically insignificant corresponding downward shift in thb. in a worst case, this shift may cause the reporting of a thb result approximately 5% lower than the actual thb value (e.G. an actual value of 10 g/dl is reported as 9.5 g/dl). the shift presents a low risk to health in the intended clinical uses associated with the avoximeter system.
  • Acción
    Zoll Medical is advising users of the possibility of a downward shift in tHb values with the affected lots.

Device

AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures)...
  • Modelo / Serial
    AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). An in vitro diagnostic medical device (IVD).Product Code: C100BLot Numbers: 607-108, 607-109, 607-110, 607-111, 607-112, 607-114, 607-115, 607-116, 607-117, 607-118, 607-119, 607-120, 607-122, 607-123, 607-124ARTG Number 262423
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd