Events

Retiro De Equipo (Recall) de Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. 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-2014-RN-00562-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-21
  • 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-2014-RN-00562-1
  • 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 some ultrasonic transducer kits were potentially assembled with incorrect mounting screws. one of these transducers may have been installed on the system during a recent instrument repair. over time the screws can become loose if a combination of correct and incorrect screws are used and possibly cause incorrect probe wash, splashing in the reaction vessels (rv), incorrect particle suspension in the reagent pack, or incorrect rv mix due to alignment of the probe to wash tower/rv leading to assay imprecision. this may cause erraneous but believable results and/or delay of results due to transducer alignment error.
  • Acción
    Users are advised to review historical QC data and System Check results since the transducer was installed for any indication of a potential problem and determine whether a review of patient test results is warranted. A service representative will be contacting users to schedule a service visit to confirm that their transducer is properly installed.

Device

Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagno...
  • Modelo / Serial
    Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd