Events

Retiro De Equipo (Recall) de Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD) With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA tests

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abacus ALS 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-01452-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-04
  • 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-01452-1
  • 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
    Erroneous results may occur as a result of a software issue with all versions of the phadia prime software up to and including version 2.1.4 connected to the phadia 250, phadia 2500e/ee and phadia 5000e/e+e instruments when running elia tests under specific scenarios as described below.The issue will cause the software to disregard default dilution factors for rejected samples, when using the “ok to all” function for retesting of samples if the following criteria are met: 1. more than one assay result are rejected within the same method -and- 2.The rejected results are run with tests which have different default dilution factorsif the two above scenarios occur at the same time, all samples will be retested with the dilution factor based upon the first rejected sample and assay dilution factor.
  • Acción
    Abacus ALS is advising customers that this issue will be corrected through a mandatory update of the Phadia Prime software. A representative from Abacus ALS will be in contact with users as soon as the update is available. A copy of the customer letter should be retained in a prominent position until the update has been completed.

Device

Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD...
  • Modelo / Serial
    Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD)With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA testsARTG Number: 229542
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd