Events

Retiro De Equipo (Recall) de Pipet Tips used with AutoDG System. An in vitro diagnostic medical device

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-01481-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-12-08
  • 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-01481-1
  • 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
    This failure appears as low total volume in the well of the autodg droplet plate after automated droplet generation, and results in low droplet counts when analyzing data in quantasoft. the failure is most frequently observed in columns 2 and 8 of the droplet plate, which corresponds to the fourth column of pipet tips in each box (when loaded with the box label facing front). this issue may impact pipet tip lots listed in the product details table above shipped in 2017and is most frequently observed with pipet tips from column 4 of the pipet tip box. this defect has no safety or efficacy impact, and will not result in erroneous results.
  • Acción
    Bio-Rad has decided to continue to ship pipet tips with a short-term workaround detailed in the Customer Letter.

Device

Pipet Tips used with AutoDG System. An in vitro diagnostic medical device
  • Modelo / Serial
    Pipet Tips used with AutoDG System. An in vitro diagnostic medical deviceProduct Number: 1864120, 1864121, 12003010Lot Numbers: PR136933, PR137957, PR138863, PR139939, PR136556, PR136109, PR134751, PR135656, PR135220ARTG Number: 296086
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd