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U.S. Department of Health and Human Services

Class 2 Device Recall Luminex xTAG

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  Class 2 Device Recall Luminex xTAG see related information
Date Initiated by Firm May 24, 2011
Date Posted August 31, 2011
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-3112-2011
Recall Event ID 59345
510(K)Number K093420  
Product Classification Drug metabolizing enzyme genotyping systems - Product Code NTI
Product 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.
Code Information Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
Recalling Firm/
Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6131
For Additional Information Contact
512-219-8020 Ext. 202
Manufacturer Reason
for Recall
Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
FDA Determined
Cause 2
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.
Quantity in Commerce 45 kits
Distribution Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NTI and Original Applicant = LUMINEX MOLECULAR DIAGNOSTICS, INC.