Device recall
Z-2362-2026: Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number…
FDA device recall · Class II · The Binding Site Group, Ltd.
Key facts
| Recall number (Z-number) | Z-2362-2026 |
|---|---|
| Recall event | 98830 |
| Product | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with… |
| Product code | OTA |
| Recalling firm | The Binding Site Group, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K250159 |
| 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