Events

Rappel de SSP UNITRAY - HIGH RESOLUTION CLASS I

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LIFE TECHNOLOGIES CORPORATION.

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
    17645
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-29
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Internal investigation has confirmed that primer mix b-086 found on lane 83 in the b high resolution allset gold and ssp unitray kits and on lane 9 of the b17 ssp unitray and allset gold kits gives a false negative for the b*47:03 allele according to the labeling. however the primer mix b-086 is functioning as originally designed. the b*47:03 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing due to lack of sample availability.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Modèle / numéro de série
    Model Catalog: 47230-3 (Lot serial: 009 984375); Model Catalog: 47300-10 (Lot serial: 009 984375); Model Catalog: 47230-3 (Lot serial: 010 1103786); Model Catalog: 47300-10 (Lot serial: 010 1103786); Model Catalog: 47230-3 (Lot serial: 004 743203); Model Catalog: 47300-10 (Lot serial: 004 743203); Model Catalog: 47230-3 (Lot serial: 008 709385); Model Catalog: 47300-10 (Lot serial: 008 709385); Model Catalog: 47230-3 (Lot serial: 008 757730); Model Catalog: 47300-10 (Lot serial: 008 757730); Model Catalog: 47230-3 (Lot serial: 008 800850); Model Catalog: 47300-10 (Lot serial: 008 800850); Model Catalog: 47230-3 (Lot serial: 008 839301); Model Catalog: 47300-10 (Lot serial: 008 839301); Model Catalog: 47230-3 (Lot serial: 008 873000); Model Catalog: 47300-10 (Lot serial: 008 873000); Model Catalog: 54020D (Lot serial: 009 979631); Model Catalog: 47230-3 (Lot serial: 009 910766); Model Catalog: 47300-10 (Lot serial: 009 910766)
  • Description du dispositif
    B17 SSP UniTray Kit/B Locus High Res SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION