Events

Retiro De Equipo (Recall) de Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bio-Rad Laboratories 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-00241-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-28
  • 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-00241-1
  • 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
    Bio-rad has identified an issue in relation to unexpected reactions primarily on eluates and qc samples but also with some patient samples when using id-diacell products. there is the potential for false positive results.
  • Acción
    Bio Rad Laboratories is advising users to re-test with a new kit if they are doubtful of the results and if doubts remain after re-testing, to use an alternative testing method. Users are further advised to disseminate this information to relevant personnel within their facilities.

Device

Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCel...
  • Modelo / Serial
    Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P Multiple Catalogue NumbersAll unexpired lotsARTG Number: 213161
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd