Retiro De Equipo (Recall) de CELL-DYN Emerald Cleaner. 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 Abbott Australasia Pty Ltd Diagnostic Division.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Abbott has identified occurrences where the cell-dyn emerald analyser generates quality control (qc) out of range low for parameters rbc and plt. abbott is continuing to investigate but immediate actions by the laboratory are necessary. abbott has no evidence that there is impact to generated patient results. there is a potential for delay in results due to qc out of range.
  • Acción
    Abbott is advising users to switch to an alternative lot of Cleaner reagent if available, and destroy any remaining inventory of the affected lots. If users are not experiencing the error and do not have an alternative lot to use, please order a replacement and continue to use the reagent provided internal QC results remain in specification. Users are advised to contact customer support if they are experiencing the error and do not have an alternative lot available. This action has been closed-out on 26/05/2017.


  • Modelo / Serial
    CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD)List number: 09H46-02Lot numbers: 6853, 6901Expiry date: 31 July 2017Lot number: 6953Expiry date: 30 Sep 2017Lot Numbers: 6991Expiry date: 30 Nov 2017Lot Numbers: 7024, 7027Expiry date: 31 Dec 2017Lot Number: 7044Expiry date: 31 Jan 2018Lot Number: 7082Expiry date: 28 Feb 2018Lot Number: 7110Expiry date: 31 Mar 2018Lot Number: 7119Expiry date:30 Apr 2018ARTG number: 225068
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source