Events

Retiro De Equipo (Recall) de Valproic Acid and Antibiotic TDM Multi-Calibrator. 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 Beckman Coulter Australia 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-00749-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-14
  • 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-00749-1
  • 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
    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.
  • Acción
    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).
  • Modelo / Serial
    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