Events

Recall of MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. 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 Abacus dx 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-2018-RN-00403-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00403-1
  • 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 following issues have been identified with mia fora ngs hla server and software versions 3.0 and 3.1:1. an anomaly in the mia fora ngs software involving the mismatch in exon (mme) column of the allele candidate table for drb1,3,4,5 and dqb1;2. class i hla-a primers do not cover the complete 5' and 3' untranslated regions (utr) as described in the imgt database;3. for class ii, the reverse primers for dpb1 overlap a few bases on exon 4; the reverse primer for dpa1 overlaps the last few bases of the 3' end of exon 4; exon 6 of dqb1 is not included in the amplified product; and4. the lack of polymorphisms in a region of certain allele combinations of hla class i genes may make it challenging to determine the correct phasing for heterozygous samples.
  • Action
    Abacus is advising customers that the issues will be corrected in the next revision of the MIA FORA NGS FLEX Software which will include a revised Package Insert to clarify existing or add additional assay limitations. It expected that this software will be released in August 2018. Until the next revision is available, users should refer to the Appendix provided with the Customer Letter to manually review results.

Device

MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device ...
  • Model / Serial
    MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)MIA FORA NGS HLA Server, Linux SR-790-00017 or Windows SR-790-00020MIA FORA NGS Software, Linux SR-850-00043, Windows SR-850-00062 or Registry SR-790-00068ARTG Number: 288607(Abacus dx Pty Ltd - Interpretive software IVDs)
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd