Device recall
Z-2937-2026: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test…
FDA device recall · Class II · Bioporto Diagnostics A/S
Key facts
| Recall number (Z-number) | Z-2937-2026 |
|---|---|
| Recall event | 99266 |
| Product | ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. |
| Product code | PIG |
| Recalling firm | Bioporto Diagnostics A/S |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232761 |
| FEI number | 3010739981 |
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