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
    23933
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-04-17
  • 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
    One complaint regarding this issue has been received. one customer complaint (pr184220) was recorded. a customer reported that the reactivity for lanes 13 27 30 39 and 40 was negative for the dpb1*99:01 allele when the labeling of the dpb1 ssp unitray 12 tests kit (451606d) indicates the reactivity should be positive. the labeling discrepancy may lead to potentially mistyping a dpb1*99:01 allele (population frequency < 0.01%) as a dpb1*39:01 allele. after investigation it was determined that the dpb1 ssp unitray with taq 12 tests kit (451616d) and the allset gold dpb1 high res ssp kit (54070d) are also affected by the labeling issue since they contain the same primer present in the dpb1 ssp unitray 12 tests kit (451606d). life technologies confirmed the issue on 11 march 2015.

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: 009 1450550); Model Catalog: 54070D (Lot serial: 009 1544263); Model Catalog: 54070D (Lot serial: 009 1608835); Model Catalog: 54070D (Lot serial: 009 1377591); Model Catalog: 54070D (Lot serial: 009 1618548)
  • Description du dispositif
    DPB1 SSP UNITRAY W/TAQ 12 TEST DPB1 SSP UNITRAY 12 TESTS
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION