Recall Z-2937-2026 · PIG Acute Kidney Injury Test System
Bioporto Diagnostics A/S
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
| Date | Aug 12, 2026 (initiated May 18, 2026) |
| Status | Open, Classified |
| Reason | 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 intended users. |
| Root cause | Nonconforming Material/Component |
| Action | A Quality Notification dated 6/3/26 was sent to consignees via email notifying them of the recall. Consignees in the US are to coordinate replacement of devices. ROW Consignees are to scrap unopened kits in accordance with local requirements and request replacements. |
| Quantity | 400 units |
| Distribution | Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232761 | ProNephro AKI (NGAL) Bioporto Diagnostic, Inc., Dec 7, 2023 |