Events

Retiro De Equipo (Recall) de Liquichek Specialty Immunoassay Controls. 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 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-2016-RN-00146-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-08
  • 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-2016-RN-00146-1
  • 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 have observed that intact pth may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts. there is a possibility that intact pth values in the lots affected may gradually shift down due to a decrease in stability when the product is stored at 2 to 8°c. the claims for intact pth have been revised from 23 days to 7 days.Although unlikely, the reported issue may result in a delay in result reporting or the false signalling of an in-control situation.
  • Acción
    Bio-Rad is advising users not to use the control for intact PTH beyond 7 days when stored at 2 to 8°C. Users are able to obtain a revised package insert with the updated stability time frames from http://myeinsters.qcnet.com

Device

Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)Master Lot Numbers:57430, 57440, 57450, 57460, 57470, 57480, and 57490ARTG Number: 194959
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd