Events

Retiro De Equipo (Recall) de Coulter LH and HmX Analysers. 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-2017-RN-00820-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-27
  • 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-00820-1
  • 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 determined that additional clarification for the blast suspect messages is necessary. in rare situations, the lh 750, lh 780, lh 500 and hmx analysers may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as the properties of blasts in certain samples. if these limitations are not clearly understood or are misinterpreted, in rare situations there could be a delay in the recognition, diagnosis and treatment of conditions associated with blasts in the peripheral blood.
  • Acción
    Users are asked to refer to the modified information for both the Suspect messages and Limitations sections for the Differential as contained in the Customer Letter.

Device

Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)Coulter LH 750 AnalyserReference Numbers: 6605632, A85570, A68807 Coulter LH 780 AnalyserReference No: 723585, A90728, A68808 Coulter LH 500 AnalyserReference No: 178832, 178833, 178834, A91062, A90994 Coulter HmX CP AnalysersReference No: 6605522, 6605523, 6605524 Coulter HmX AL AnalysersReference No: 6605525, 6605526, 6605527, A85566, A85564 All software versionsARTG Number: 177999
  • Clasificación del producto
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd