Events

Rappel de SSP UNITRAY - HIGH RESOLUTION CLASS II

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
    98310
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-02-27
  • 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
    There are three reactivity updates with respect to these kits: 1. in primer mix dpb004 (lane 4) the reactivity for the dpb1*31:01 has been updated from positive to negative. prior to this update in the presence of the dpb1*31:01 allele users may have obtained a negative reaction leading to a no-type result. 2. in primer mix dpb027b (lane 27) and dpb039a (lane 39) the reactivity for the dpb1*88:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*88:01 allele users may have obtained a negative reaction leading to a no-type result. 3. in primer mix dpb039a (lane 39) the reactivity for the dpb1*29:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*29:01 allele users may have obtained a negative reaction leading to a no-type result.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Modèle / numéro de série
    Model Catalog: 451606D (Lot serial: > 10 numbers contact mfg); Model Catalog: 451616D (Lot serial: > 10 numbers contact mfg); Model Catalog: 54070D (Lot serial: 008 1127336); Model Catalog: 54070D (Lot serial: 008 1204422); Model Catalog: 54070D (Lot serial: 008 1256851); Model Catalog: 54070D (Lot serial: 009 1377591); Model Catalog: 54070D (Lot serial: 008 1073448)
  • Description du dispositif
    DPB1 SSP UNITRAY 12 TESTS DPB1 SSP UNITRAY W/TAQ 12 TEST
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION