Events

Recall of Human Total 25-OH Vitamin D IVD ELISA 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-2015-RN-01033-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01033-1
  • 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 supplier has advised they are not authorised to supply the kit outside of the us, however there is no health risk associated with use of the kit.
  • Action
    In Vitro Techologies is advising users to stop using the product and discard any remaining stock, for credit. This action has been closed-out on 07/03/2016.

Device

Human Total 25-OH Vitamin D IVD ELISA Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Human Total 25-OH Vitamin D IVD ELISA Kit. An in vitro diagnostic medical device (IVD).Item number: RDKAP1971Lot number: 150601 ARTG Number: 251953
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd