Rappel de LABType DNA Typing Tests (for transplant compatibility analysis). 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 Bio-Strategy 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-2016-RN-01380-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-17
  • Pays de l'événement
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
  • 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
    Lot specific user documents and catalog files updated for the january 2016 nomenclature contain incorrect allele specificity information for certain beads for particular labtype dna typing tests. the affected documents and catalog files were accessible between the date period july 29, 2016 to august 22, 2016.
  • Action
    Bio-Strategy has provided customers with corrected lot-specific user documents and catalog files, and advised that results obtained using the affected products and incorrect user documents and catalog files should be reviewed using the corrected information. This action has been closed-out on 17/05/2017.

Device

  • Modèle / numéro de série
    LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD).SSO Class II DRB1 (Catalog ID: RSSO2B1, RS02B1T)HD Class II DRB1 (ID: RSSOH2B1, RSOH2B1T, RSSOH2B1X)SSO Class II DQA1/DQB1 (ID: RSSO2Q, RSSO2QX, RSO2QT)SSO MICA (ID: RSSOMICA)SSO Class I Bw4 Supplement (ID: RSSO1S4, RSO1S4T)XR Class II DRB1 (ID: RSSOX2B1, RSOX2B1T)CWD Class II DRB1 (ID: RSSOW2B1, RSOW2B1T)Multiple lots affected.ARTG Numbers: 236737 & 236738
  • Manufacturer

Manufacturer