Events

Recall of Human IgM kit for use on SPAPLUS

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-2017-RN-00916-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00916-1
  • 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
    An investigation by in vitro technologies investigations of specific lots of human igm kit for use on spaplus have identified that the calibration stability has decreased in comparison to historical released kits. users will be able to identify when the calibration is no longer valid, as control values will fall outside of the provided acceptable limits.
  • Action
    The Binding Site recommends the following: 1. Batch sample analysis, when possible; 2. Recalibrate the assay when QC results have deviated outside of the specified range; 3. Contact In Vitro Technologies for any further guidance or additional kit requirements; and 4. Complete the acknowledgement form supplied with the customer letter, even if you do not have any of the affected product, and return it by email to QRA@invitro.com.au

Device

Human IgM kit for use on SPAPLUS
  • Model / Serial
    Human IgM kit for use on SPAPLUSItem Number: TBSNK012SLot Numbers: 400872 and 407480ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd