Events

Recall of LIFECODES LifeScreen Deluxe (LMX). 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 Diagnostic Solutions 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-01026-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01026-1
  • 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
    During stability testing at test point 9 months, with lmx lot 3002350, immucor observed false positive results with a single sample. the sample is expected to test negative for both hla class i and class ii. the sample gave a qualitative result of ci (-), cii (+), indicating a false positive for hla class ii.
  • Action
    Diagnostic Solutions is advising users to destroy any remaining stocks of the affected lots. It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 19/08/2016.

Device

LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).Code Number: TL628215Lot Number: 3002350Expiration Date: 15 Nov 2015ARTG Number: 217870
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd