Recall Z-3112-2011 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
Luminex Corporation
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 anti
| Date | Aug 31, 2011 (initiated May 24, 2011) |
| Status | Terminated |
| Reason | Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays. |
| 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 | 45 kits |
| Distribution | Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) Luminex Molecular Diagnostics, Inc., Aug 26, 2010 |