Events

Rappel de Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.

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-00283-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-04-04
  • 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-00283-1
  • 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
    Abacus has been advised by immucor (the manufacturer), that as a result of a complaints investigation, it has been determined that the serological group for the b*27:08 allele was incorrectly assigned as bw4. the correct serological group assignment for b*27:08 is bw6. this assignment was part of the 3.29.0 allele database update. immucor confirm that there is no impact to the lifecodes hla-b sso typing kits themselves.Abacus technical support has confirmed that australian customers do not currently utilise this component of the software, however, are rectifying the issue so it does not present a hazard in the future.
  • Action
    Abacus dx is advising that Immucor has created an executable file to correct the serological group assignment for B*27:08 when using the s.29.0 database update, which is available on the Immucor website. Customers are asked to upload this executable file before running LIFECODES HLA-B SSO typing kits. Instructions for uploading this file to correct the serological group alignment are outlined on the Customer Letter.

Device

Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database...
  • Modèle / numéro de série
    Immucor MATCH IT! DNA Software version 3.29.0 (released 30 Jan 2018) for use with Allele Database used with LIFECODES HLA-B SSO Typing Kits. In vitro diagnostic medical devices.LIFECODES HLA-B SSO Typing Kit Affected Lots: 01117A (exp 30/11/2018) and 06036A (exp 31/05/2018)Typing Kit Catalogue Numbers: TL628915 and TL628915sARTG Numbers: 257272 , 217871
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd