Events

Retiro De Equipo (Recall) de N Latex Carbohydrate-deficient Transferrin (CDT). 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-2017-RN-00452-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-04-07
  • 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-2017-RN-00452-1
  • 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 observed lower values for carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to former lots. cdt results in absolute concentrations are influenced by the patient’s total transferrin levels and therefore results are reported as ratio of cdt to total transferrin, called %cdt. as the transferrin determination with n antiserum to human transferrin is not affected, the lower cdt result leads to calculated %cdt values that show a negative bias of approximately 10 to 15% compared to former lots. this could result in a shift of weak positive patient samples into the reference range of 1.19 – 2.47 %cdt which was derived from a study population of healthy adults. it is not expected that samples from patients with chronic heavy alcohol consumption will be misclassified.
  • Acción
    Siemens is advising users to discontinue use of and discard the affected lots. Replacement stock will be provided by Siemens. It is recommended that users review the customer letter with the laboratory Medical Director.

Device

N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).Catalogue Number: OPCS035Siemens Material Number: 10445996Lot Numbers: 45834 & 45987 (Expiry 3 Jun 2017); 46116, 46244, 46388 & 46568 (Expiry 10 Oct 2017)ARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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