Events

Retiro De Equipo (Recall) de RE51021 / MuSK-Ab ELISA

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-01435-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-11-23
  • 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-01435-1
  • 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 notice is to inform you about a recall action for ibl international product ibre51021 musk-ab elisa lot emu124 with expiry date 31-10-2018. this action has been undertaken by the australian distributor abacus als following consultation with the therapeutic goods administration (tga). no other lot numbers of this product are affected by this recall. description of the problem: the user of this assay may notice that the antiserum (#kemu521, lot: s882) and assay buffer (#kemu751, lot: s881) appears contaminated (cloudy and contain particles). this issue is caused by a contamination of lot # emu124.
  • Acción
    Users should inspect stocks and quarantine all units of IBRE51021 Lot EMU124, then complete and return the supplied Reply Form as directed for stock to be recovered and replaced.Complete the Reply Form even if you have no stock which is subject to recall, as Abacus ASL requires this information to reconcile this process. Retain the letter in a prominent position for one month in case stock is in transit. If any affected stock has been transferred from your Laboratory to another, immediately let that laboratory know of the recall and inform Abacus ASL.

Device

RE51021 / MuSK-Ab ELISA
  • Modelo / Serial
    RE51021 / MuSK-Ab ELISA Lot EMU124ARTG number: 210637
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd