Events

Retiro De Equipo (Recall) de IH-1000 Immunohaemotology Analyser. 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-2013-RN-00456-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-16
  • 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-2013-RN-00456-1
  • 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
    An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present:1. ih-1000 is in status “ready to start” and:2. the user requests the unloading of a reagent rack while the system is creating the internal batch (the time slot during which the error could occur is about 2 seconds);3. another is loaded immediately afterwards in the same position.If all three conditions are present, the ih-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch.Due to a software failure, the system may only use the vial placed in the first position of the re-loaded rack for all the tests of the ongoing batch.
  • Acción
    Bio-Rad is providing end users with work around instructions to mitigate the risk of incorrect results. A permanent correction will be made in the next software update.

Device

IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)
  • Modelo / Serial
    IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)Product REF: 001000All software versionsARTG number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd