ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
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.
| Recalling firm | Bioporto Diagnostics A/S |
|---|---|
| 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. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | May 18, 2026 |
| Region | Denmark |
| 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. |
| Quantity | 400 units |
| Code/Lot | Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. |
| Type | Voluntary: Firm initiated |
| Recall number | Z-2937-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-2937-2026)
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