Drug recall
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20…
FDA recall event 98830 · Class II · The Binding Site Group, Ltd.
Key facts
| Event ID | 98830 |
|---|---|
| Recall numbers | Z-2362-2026 |
| Recalling firm | The Binding Site Group, Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include… |
| Initiation date | Apr 16, 2026 |
| Report date | Jun 17, 2026 |
| City | Birmingham |
| Country | United Kingdom |
| FEI number | 3002808340 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: