Device Recall Luminex xTAG

Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.

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.