Events

Recall of Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). 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-01298-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01298-1
  • 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
    It was determined through the course of a post-release product investigation that the control values on an affected lot of the freelite human kappa free kit require a reassignment which is 21% lower than the value established during the manufacture of the product. with the currently assigned values, if the controls are out of range (±20% of the concentration stated), then results of the run should not be accepted, which may lead to a delay in reporting results.
  • Action
    In Vitro Technologies are providing users with revised values for the quality controls, which are to be used for the remainder of the shelf life of the Freelite Human Kappa Free Kit. This action has been closed out on 14 June 2017.

Device

Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An...
  • Model / Serial
    Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An in vitro diagnostic medical device (IVD)Item Number: TBSLK016AULot Number: 358004ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd