Events

Retiro De Equipo (Recall) de ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + Screen

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bio-Rad Laboratories 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-2018-RN-00318-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-20
  • 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-2018-RN-00318-1
  • 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
    Bio-rad laboratories have been able to confirm an increased level of antibody of undetermined specificity (aus) when using some reagents of the id-system intended for irregular antibody screening and identification.
  • Acción
    BioRad is advising that the capacity of impacted lots of ID-Cards to detect and identify clinically significant antibodies is not affected by this issue. For that reason users may continue to use these products for their intended purpose. In the event users experience an AUS level impacting the ability to render final results, users should consider using an alternative method such as the tube method to verify results.

Device

ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro d...
  • Modelo / Serial
    ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + ScreenProduct ID Numbers: 50531, 50540, 50571, 50581,50682Multiple Catalogue and Lot NumbersARTG Number: 212527(Bio-Rad Laboratories - Multiple blood grouping and typing IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd