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U.S. Department of Health and Human Services

Class 2 Device Recall Luminex xTAG

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 Class 2 Recall
Luminex xTAG
see related information
Date Posted August 31, 2011
Recall Status1 Terminated on March 23, 2012
Recall Number Z-3112-2011
Recall Event ID 59345
Premarket Notification
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/
Manufacturer
Luminex Corporation
12212 Technology Blvd
Austin, Texas 78727-6131
Consumer Instructions Contact the recalling firm for information
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
OTHER/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NTI and Original Applicant = LUMINEX MOLECULAR DIAGNOSTICS, INC.
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