Events

Recall of Human IgG4 Kit Immage KitProduct code: LK009.IM

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-2014-RN-00991-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00991-1
  • 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
    As a result of customer complaints, the manufacturer (the binding site) identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
  • Action
    In Vitro Technologies is advising that care must be taken when interpreting results from patients suspected of suffering from IgG4-RSD and recommend that for any patient where the IgG4 concentration does not concur with their clinical history or other test results, the sample should be re-assayed at different dilutions to identify if any antigen excess is occurring. In addition, the IgG4 result should be equated to the total IgG result and any significant discrepancies investigated. The instructions for use have been updated to include these recommendations. This action has been closed-out on 03/02/2017.

Device

Human IgG4 Kit Immage KitProduct code: LK009.IM

Manufacturer

In Vitro Technologies Pty Ltd