Events

Recall of Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 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-2017-RN-00997-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00997-1
  • 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
    Diagnostic solutions has been informed by the manufacturer lmmucor gti diagnostics, that there is an error in the probe lot specific files and probe hit tables in the match it! dna 3.27.0 allele database update sent to customers in may 2017. the error impacts specific kits and lots numbers only.The error results in an incorrect typing for some non-common well defined alleles. however, the affected alleles are still correctly typed at low resolution.
  • Action
    1. Complete the supplied response form. If any of the affected stock could have been transferred from your Laboratory to another, please immediately forward a copy of this letter to relevant staff. 2. Retain this letter in a prominent position until the database is updated. 3. A representative from Diagnostic Solutions will be in contact with users as soon as the database update is available. 4. Consider re-analysing the data once the database update is made.

Device

Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical devi...
  • Model / Serial
    Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit. An in vitro diagnostic medical device (IVD)HLA-DRB1 SSO Typing KitSupplier Code: 628923Lot Numbers: TL628923 and TL628923sLot Numbers: 04226A and 11125AHLA-DQA1/B1 SSO Typing Kit Supplier Code: 628930Lot Numbers: TL628930, TL628930s and TL628930pLot Numbers: 3004970, 06306A and 10205AARTG Numbers: 217874 and 217873
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd