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.
FDA Recall Z-3112-2011 · Posted 2011-08-31
Advertisement
Recalling FirmLuminex Corporation
Recall StatusTerminated
Product CodeNTI
Date Initiated2011-05-24
Date Terminated2012-03-23
Product Quantity45 kits
Reason for Recall
Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement