Device recall
Z-1053-2017: Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S…
FDA device recall · Class II · The Binding Site Group, Ltd.
Key facts
| Recall number (Z-number) | Z-1053-2017 |
|---|---|
| Recall event | 76050 |
| Product | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases |
| Product code | DEH |
| Recalling firm | The Binding Site Group, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2017 |
| 510(k) numbers | K062372 |
| FEI number | 3002808340 |
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