Class II — Bioporto Diagnostics A/S
| Recalling firm | BioPorto Diagnostics A/S |
|---|---|
| Registered facility | BIOPORTO DIAGNOSTICS A/S (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. |
| 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. |
| Initiated | 2026-05-18 |
| Classified | 2026-08-12 |
| Recall number | Z-2937-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bioporto Diagnostics A/S (Z-2937-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99266/
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