Events

Recall of MIA FORA NGS Software v3.27.0. 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-01303-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01303-1
  • 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 advised that as a result of a complaint investigation, it has been determined that mia fora ngs software is impacted by an error in the v3.27.0 reference database update. customers testing all 11 hla genes, 9 hla genes and 6 hla genes with the mia fora ngs flex hla kits are impacted. reference sequences specific to hla-drb6 and other non-target reference sequences were inadvertently omitted from the v3.27.0 reference database and as a result, this may impact the accuracy of the automatic calls and the need to manually review results. this is most frequently observed with hla-dpb1 results.
  • Action
    Diagnostic Solutions will be in contact with users when a software update is available to include the revised reference database. In the interim, users may utilise either of the following options: 1. Continue use of the v3.27.0 reference database and manually inspect all DPB1 results pending availability of the corrected database; or 2. Revert to v3.24.0. Guidance on how to do this may be provided upon request by Immucor. Note: after reverting to v3.24.0 users must reanalyse projects previously analysed with the v3.27.0 reference database using the v3.24.0 reference database.

Device

MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)ARTG Number: 288607
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd