Events

Retiro De Equipo (Recall) de Reagent Red Blood Cells 0.8% Resolve Panel C. 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-2016-RN-01599-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-13
  • 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-01599-1
  • 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
    Ortho clinical diagnostics (ortho) has received an increase in customer complaints and has confirmed the intermittent presence of marked haemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation, and the root cause for the marked haemolysis, has been identified as microbial contamination. there is a single lot of one product affected in australia, reagent red blood cells 0.8% resolve panel c.If markedly haemolysed red cell products are used in testing, erroneous (false positive or false negative) results may be generated, which can potentially lead to patient harm. to date, ortho has received no reports of erroneous patient/donor results due to this issue.
  • Acción
    OCD is advising users to visually inspect all products prior to use and, as per the instructions for use, do not use red cell products if marked haemolysis or evidence of contamination is observed. If the product has marked haemolysis, contact Ortho Care Technical Solutions Center to report the issue so that the product can be replaced or credited. This action has been closed-out on 26/05/2017.

Device

Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).Product Code: 6902319Lot Number: VRC226Expiry: 3 January 2017ARTG Number: 254792
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd