Events

Recall of Valproic Acid and Antibiotic TDM Multi-Calibrator. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00749-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00749-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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).
  • Model / 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