Events

Retiro De Equipo (Recall) de Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)(for use with the Access family of immunoassay systems)

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-00679-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-01
  • 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-00679-1
  • 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 through customer feedback and an internal investigation that the four (4) access immunoassays listed are susceptible to biotin interference. during interference testing, the interference occurred with samples that contained 100 ng/ml of biotin. this level of biotin is greater than the maximum biotin concentration observed in the normal healthy population.Specimens from patients who are undergoing biotin therapy and/or ingesting biotin supplements may contain high levels of biotin. the higher biotin concentration in these specimens interferes with the biotin-streptavidin assay design of these four affected access assays and may cause false low results (for the access gi monitor and thyroglobulin assays) and false high results (for the access free t4 and total t3 assays).
  • Acción
    Beckman Coulter will update the "Limitations" section of the Access Total T3, Thyroglobulin, Free T4, and GI Monitor Instructions for Use with this biotin interference information. Users are requested to interpret the results in light of the total clinical presentation of the patient (including symptoms, clinical history, data from additional tests, and other appropriate information).

Device

Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitr...
  • Modelo / Serial
    Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)(for use with the Access family of immunoassay systems)Access Total 3Reference Number: 33830Access ThyroglobulinReference Number: 33860Access Free T4Reference Number: 33880Access GI MonitorReference Number: 387687All LotsARTG Numbers: 213975 and 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd