Events

Rappel de Valproic Acid and Antibiotic TDM Multi-Calibrator. 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 Beckman Coulter Australia Pty Ltd.

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-2017-RN-00749-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-14
  • 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-2017-RN-00749-1
  • 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
    Beckman coulter is advising of a change in the hazard classification of valproic acid osr6415 and antibiotic tdm multi-calibrator odc6413. test results are not affected. valproic acid (osr6415) and tdm multi-calibrator (odc6413) are missing required hazard labelling as per globally harmonised system of classification and labelling of chemicals (ghs) regulation. products are incorrectly labelled as non-hazardous instead of hazardous. the change in hazardous information is for the following ingredients: 0.1-1% vancomycin in antibiotic tdm multi-calibrator; and.
  • Action
    Beckman Coulter has updated the Safety Data Sheet (SDS) for Valproic Acid and Antibiotic TDM Multi-Calibrator and the new Hazardous classification, pictograms and signal word will be displayed in future on the product labels and in the GHS Hazard Classification section of the IFU for each product, namely BLOSR6415 and BLODC6413. In the interim, this information is provided in the customer letter. Users are to share the letter with their local Environmental Health and Safety representative and ensure compliance with local procedures for disposal and handling of Hazardous material.

Device

Valproic Acid and Antibiotic TDM Multi-Calibrator. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Valproic Acid and Antibiotic TDM Multi-Calibrator. An in vitro diagnostic medical device (IVD).Reference Numbers: OSR6415 and ODC6413All LotsARTG Number: 200020
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd