Retiro De Equipo (Recall) de MULTIGENT Ammonia Ultra Reagent. 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
    Due to a manufacturing issue with multigent ammonia ultra reagent, list number 6k89-30, lot 50083y600 are being removed from use. this lot is producing results below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. quality control results are not affected. complaints relating to out of range patient results have been confirmed through internal testing as no measurable ammonia values were obtained for samples tested per package insert instructions. a review of complaint data for the impacted lot of ammonia also indicates there is potential for lower than expected results to be generated, however, this has not been confirmed during internal testing. based on testing of all in-date lots no other reagent lots or sample tube types are known to be impacted.
  • Acción
    Users are requested to inspect their stock and destroy any inventory affected by this recall. Abbott is advising users to follow laboratory protocol regarding the review of previously generated patient results. This action has been closed-out on 26/08/2016.


  • Modelo / Serial
    MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)List Number: 6K89-30Lot Number: 50083Y600Expiration Date 31 Jul 2016ARTG Number: 203299
  • 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