Device recall
Z-3112-2011: xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-3112-2011 |
|---|---|
| Recall event | 59345 |
| Product | 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… |
| Product code | NTI |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2012 |
| 510(k) numbers | K093420 |
| FEI number | 3002524000 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database