Events

Recall of Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). 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 Life Technologies Australia 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-01413-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01413-1
  • 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 has been identified that the enzyme digestion reagent (reagent 2) contains 1.3x the normal amount of enzyme (pepsin) leading to excessive pepsinisation of cells. this may cause loss of tumour cell morphology and inadequate hybridization of fish/cish probes. the over pepsinisation will be obvious to the user when examining slides under a microscope.
  • Action
    Life Technologies is advising users to dispose of affected stock. Credit will be issued for the affected stock. Unaffected stock is expected to be available from 31 November 2016. This action has been closed-out on 18/05/2017.

Device

Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in v...
  • Model / Serial
    Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD).Catalogue Number: 008401Lot Numbers: 1667961A (exp. 31 Jul 2016), 1713166A (exp. 30 Nov 2016), 1714439A (exp. 30 Apr 2017), 1763308A (exp. 28 Feb 2018)ARTG Number: 212745
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd