Events

Recall of Freelite Human Kappa Integra Kit. 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 In Vitro Technologies 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-2016-RN-00231-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00231-1
  • 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
    The manufacturer has determined that the affected calibrator and controls require a reassignment which is 16% lower than the value established during the manufacture of this product. in vitro technologies is advising users to recalibrate the affected lots with the new calibrator values provided. the assay bias of 16% would result in a minimal change to low values. however the difference would be proportionately greater at higher values.
  • Action
    In Vitro Technologies is providing users with revised target and range values to be used with the affected kits. The Director of Chemical Pathology should be consulted to determine the need for a review of results previously reported using this kit

Device

Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)Item Numbers: TBSLK01610RI and TBSLK016ILot Numbers: 354992, 355769ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd