Events

Retiro De Equipo (Recall) de IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). 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 Beckman Coulter 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-00437-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-14
  • 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-00437-1
  • 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
    The manufacturer, iris international has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes.
  • Acción
    Beckman Coulter is advising users to ensure the directions for handling and storage of the control material as per the IFU are followed to prevent premature degradation of the control material. Users are advised to discard the bottle if the QC fails and use alternative bottles in the kit. If the problem persists, request a product replacement from Beckman Coulter. This action has been closed-out on 03/02/2017.

Device

IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin)....
  • Modelo / Serial
    IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). An in vitro diagnostic medical device (IVD)Reference Number: 800-7211Lot Numbers: 336-15, 343-15 (Exp April 2016) Lot Numbers: 004-16,006-16,019-16,021-16,182-15 (Exp May 2016)Reference Number: 800-7702Lot Numbers: 313-15, 336-15 (Exp April 2016) Lot Numbers: 004-16 (Exp May 2016)Reference Number: 800-7211Lot Number: 309-15 (Exp April 2016)ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd