Events

Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. 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 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-2017-RN-00361-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-17
  • 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-00361-1
  • 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 confirmed that some lots of vitros nt-probnp reagent packs exhibited the potential for an increased frequency of calibration failures, with an unexpected increase in signal for the level 1 calibrator, potentially causing a failure of the calibration parameters. preliminary testing has indicated that the calibration failure is related to a component of the vitros nt-probnp reagent pack and is not associated with the vitros nt-probnp calibrators. please note that investigations have confirmed that the increase in signal does not affect sample results (i.E., quality control or patient samples) within the 28 day calibration cycle.
  • Acción
    Ortho Clinical Diagnostics (Ortho) is advising users that they will be sent the revised Master Calibration data to ensure successful future calibrations. In the interim, users are requested to refer to the workaround details contained in their recall notifications. Users (of Lots 1580, 1590 and 1620) who experience this issue and who no longer wish to use the affected products can have the option of having their accounts credited for the product/s discarded.

Device

VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)Unique Device Identifier Number: 10758750002061Product Code: 6502156Lot Numbers: 1570 (exp. 22 Mar 2017), 1580 (exp. 13 Apr 2017), 1590 (exp. 27 Apr 2017) and 1620 (exp. 06 Jul 2017)ARTG Number: 245492
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd