Device Recall Luminex xTAG

  • Modèle / numéro de série
    Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
  • Description du dispositif
    xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 || The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Luminex Corporation, 12212 Technology Blvd, Austin TX 78727-6131
  • Société-mère du fabricant (2017)
  • Source
    USFDA