ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
FDA device recall Z-2937-2026 · posted 2026-08-12 · Open, Classified
Recall details
- Recalling firm
- Bioporto Diagnostics A/S
- 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 intended users.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- PIG
- Quantity affected
- 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 Canad
- Date initiated
- 2026-05-18
- Date posted
- 2026-08-12
- Location
- Hellerup, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ProNephro AKI™ (NGAL) (K232761) | Bioporto Diagnostic, Inc. | 2023-12-07 |