Events

Recall of illumigene Malaria 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 Bioline Aust 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-00921-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00921-1
  • 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 manufacturer meridian has discovered that the sample preparation apparatus iv is susceptible to evaporation over the shelf life, causing low volume of the liquid reagent. post-market studies indicate that this component may not be stable through to the labelled expiration date due to this evaporation. internal testing by meridian has confirmed that the use of a low volume sample preparation apparatus component will result in an invalid test result.At this time, there is no indication that valid test results are impacted, and previously reported patient results require no additional action.
  • Action
    Meridian is requesting customers: 1. Identify existing inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015; 2. Contact Bioline directly, as necessary, for replacement product; 3. Complete and return the supplied Customer Response Form to Bioline; and 4. Upon receipt of replacement product, segregate and destroy remaining inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015. All kit components should be discarded in accordance with local regulations.

Device

illumigene Malaria Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    illumigene Malaria Kit. An in vitro diagnostic medical device (IVD).Catalogue Number: 280925Kit Lot Numbers:280925H009 Expiry: 23 August 2017Component involved: 2824.005280925H010 Expiry: 23 August 2017Component involved: 2824.006280925J011Expiry: 24 July 2018Component involved: 2824.008280925J013Expiry: 24 July 2018Component involved: 2824.009280925J015Expiry: 19 June 2018Component involved: 2824.007ARTG Number: 277788
  • Manufacturer
    Bioline Aust Pty Ltd

Manufacturer

Bioline Aust Pty Ltd