Device recall
Z-0553-2018: Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for…
FDA device recall · Class II · The Binding Site Group, Ltd.
Key facts
| Recall number (Z-number) | Z-0553-2018 |
|---|---|
| Recall event | 78934 |
| Product | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in… |
| Product code | DHR |
| Recalling firm | The Binding Site Group, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2020 |
| 510(k) numbers | K160070 |
| FEI number | 3002808340 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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