Devices

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
1 Event
- Recall of Device Recall Luminex xTAG

Manufacturer

Luminex Corporation

Manufacturer Address
Luminex Corporation, 12212 Technology Blvd, Austin TX 78727-6131
Manufacturer Parent Company (2017)
Luminex Corporation
Source
USFDA

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