Events

Recall of LIFECODES HLA-C eRES SSO Typing 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 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-2016-RN-00591-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00591-1
  • 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 determined that the threshold set for hla-c eres probes 380, 382, 384 and 385 in lot number 10235b are set high and may result in false negative probe results. the probes resolve the following cwd alleles:• probe 380 resolves c*03:06• probe 382 resolves c*12:13• probe 384 resolves c*01:08 • probe 385 resolves c*08:06.
  • Action
    Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot. This action has been closed-out on 02/02/2017.

Device

LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: TL628921Lot Number: 10235BProbes affected: 380, 382, 384, 385ARTG Number: 217872
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd