Events

Retiro De Equipo (Recall) de COULTER ReticPrep Reagent Kit (used for reticulocyte counting). 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-00151-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-08
  • 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-00151-1
  • 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
    Beckman coulter has received an increased number of customer complaints related to the inability to scan or manually enter the reticprep barcode label. the reticprep barcode label number 2 contains characters that are not recognised by the software ("+$$" instead of "22"), and due to this issue the system will not generate results.The reported issue may lead to a delay in test results reporting. however, it is unlikely to cause adverse health consequences.
  • Acción
    Beckman Coulter is advising users to follow the IFU to manually enter barcode number 2 with "22" in place of "+$$" which is printed on the label.

Device

COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical de...
  • Modelo / Serial
    COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical device (IVD)Reference Number: 7546978 Lot Number: 108912K Expiry Date: 11/12/2016ARTG Number: 223049
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd