Drug recall
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
FDA recall event 99266 · Class II · Bioporto Diagnostics A/S
Key facts
| Event ID | 99266 |
|---|---|
| Recall numbers | Z-2937-2026 |
| Recalling firm | Bioporto Diagnostics A/S |
| Product type | Devices |
| Products | ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in… |
| Initiation date | May 18, 2026 |
| Report date | Aug 19, 2026 |
| City | Hellerup |
| Country | Denmark |
| FEI number | 3010739981 |
At a glance
- 1–9 Products in this recall
- 1–9 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: