Device recall
Z-0002-2018: Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S…
FDA device recall · Class II · The Binding Site Group, Ltd.
Key facts
| Recall number (Z-number) | Z-0002-2018 |
|---|---|
| Recall event | 78047 |
| Product | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser… |
| Product code | DEM |
| Recalling firm | The Binding Site Group, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 21, 2019 |
| 510(k) numbers | K123256 |
| 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