Events

Rappel de MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abacus dx Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00403-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00403-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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 ...
  • Modèle / numéro de série
    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