Events

Rappel de Device Recall Luminex xTAG

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Luminex 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
    59345
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3112-2011
  • Date de mise en oeuvre de l'événement
    2011-05-24
  • Date de publication de l'événement
    2011-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102337
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Drug metabolizing enzyme genotyping systems - Product Code NTI
  • Cause
    Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
  • Action
    Luminex sent a "Customer Advisory" letter dated May 24, 2011, by email and courier to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to destroy any remaining product and to submit a return postcard to confirm that the consignee had been notified of the recall and had destroyed the product. For further questions please call Luminex Technical Support at 1-877-785-2323 ( US ) and 1-512-381-4397 ( Outside US ) Monday through Friday.

Device

Device Recall Luminex xTAG
  • Modèle / numéro de série
    Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Luminex Corporation

Manufacturer

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