Events

Retiro De Equipo (Recall) de Randox Myoglobin Assay

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Randox 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-00340-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-10
  • 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-00340-1
  • 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
    Randox has confirmed a change in recovery with regards to myoglobin in the lots of the liquid cardiac control listed above for the randox immunoturbidimetric method. internal testing of the affected lots has shown an increased rate of degradation for myoglobin only. new targets and control ranges have therefore been assigned for the randox immunoturbidimetric method. recovery of myoglobin for other methods quoted in the ifu has not been confirmed. customers using methods other than the randox immunoturbidimetric method should review their running iqc mean for a shift in trend which may indicate a review of the control range is required.Iqc that is reported as out of range could lead to a delay in reporting myoglobin results. since serum myoglobin is not typically used in isolation for diagnosing cardiac injury a delay in reporting these results should not pose a serious risk to health.
  • Acción
    Users are notified to remove the existing IFU from all unused stock and replace it with the lot specific document provided with the customer letter. Also, users are advised to discuss the contents of customer letter with their Medical Director and review results generated with the affected batches in line with the clinical profile of the patient.

Device

Randox Myoglobin Assay
  • Modelo / Serial
    Randox Myoglobin AssayCatalogue Numbers: CQ5051, CQ5052, CQ5053Batch Numbers: 3909CK to 3913CK; 3990CK to 3992CKARTG Number: 208141
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA