xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. T
FDA device recall Z-3112-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Luminex Corporation
- Reason for recall
- Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NTI
- Quantity affected
- 45 kits
- Distribution
- Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
- Date initiated
- 2011-05-24
- Date posted
- 2011-08-31
- Date terminated
- 2012-03-23
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) (K093420) | Luminex Molecular Diagnostics, Inc. | 2010-08-26 |