Events

Recall of Device Recall Luminex xTAG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Luminex Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59345
  • Event Risk Class
    Class 2
  • Event Number
    Z-3112-2011
  • Event Initiated Date
    2011-05-24
  • Event Date Posted
    2011-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102337
  • Notes / Alerts
    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.
  • Extra notes in the data
    Drug metabolizing enzyme genotyping systems - Product Code NTI
  • Reason
    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
  • Model / Serial
    Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
  • Product Description
    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
  • Manufacturer Address
    Luminex Corporation, 12212 Technology Blvd, Austin TX 78727-6131
  • Manufacturer Parent Company (2017)
    Luminex Corporation
  • Source
    USFDA