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.
This recall has been terminated (originally issued August 31, 2011).
- Company
- Luminex Corporation
- Recall Initiated
- May 24, 2011
- Posted
- August 31, 2011
- Terminated
- March 23, 2012
- Recall Number
- Z-3112-2011
- Quantity
- 45 kits
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
Distribution
Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
Lot / Code Info
Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
Root Cause
Other
Action Taken
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.