Events

Rappel de MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abbott Australasia Pty Ltd Diagnostic Division.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00955-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00955-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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.

Device

MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)List Number: 6K89-30Lot Number: 50083Y600Expiration Date 31 Jul 2016ARTG Number: 203299
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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
    DHTGA