Z-3112-2011

xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439...

Name: Z-3112-2011 xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439...
Creator: Luminex Corporation
Published: 2011-05-24
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2011-05-24 / Terminated / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog #... on 2011-05-24. The reason FDA records is "Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3112-2011
Status: Terminated
Initiated: 2011-05-24
Posted: 2011-08-31
Terminated: 2012-03-23
Recalling firm: Luminex Corporation
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.
Product code: NTI Drug Metabolizing Enzyme Genotyping Systems
Reason for recall: Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Product codes and lots: Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)

Product code NTI

K093420Class IIXtag Cyp2d6 Kit V3, Model I030c0300 (96 Tests/kit), Tdas Cyp2d6 Software (2030-0254)Luminex Molecular Diagnostics, Inc. / cleared 2010-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)