Events

Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products NT-proBNP Assay. 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 Ortho-Clinical Diagnostics.

¿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-2015-RN-00427-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-20
  • 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-2015-RN-00427-1
  • 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
    Internal testing by ortho-clinical diagnostics, inc. (ocd) has determined the need for revisions to the low end of the measuring range for the assay. this revision affects the limit of blank (lob), limit of detection (lod), limit of quantification (loq) and reportable measuring range.
  • Acción
    Ortho-Clinical Diagnostics, Inc. (OCD) is providing the updated Instructions For Use (IFU) and instructing the customers to implement the revisions on the VITROS System as below: - For VITROS ECi/ECiQ Systems: Scan the Magnetic Lot Card for Lot 1250 & above. - For VITROS 3600, 5600 Systems: Install ADD DRV 5815 & above. - Update the laboratory procedures and Laboratory Information System, as required. The revision to the low end of the Measuring (Reportable) Range may affect the Laboratory Information System. Users are advised to consult with their Information Technology representative to determine the impact at their facility. IFU documents are also available on the Ortho-Clinical Diagnostics, Inc. (OCD) website.

Device

VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)VITROS NT-proBNP CalibratorsProduct Code: 6802157GTIN: 10758750002078VITROS NT-proBNP Reagent PackProduct Code: 6802156GTIN: 10758750002061
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics