ProNephro AKI — Class II medical device recall Z-2937-2026
Ongoing recall by Bioporto Diagnostics A/S, reported 2026-08-19. The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal dis
| Recall number | Z-2937-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bioporto Diagnostics A/S, Hellerup, Denmark |
| Recall initiated | 2026-05-18 |
| Classified | 2026-08-12 |
| Reported by FDA | 2026-08-19 |
| Countries outside the US | CA, CL, HK |
| Quantity | 400 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05711435000156 |
| Lot numbers | 04909125, 04912125 |
| Model numbers | 08787174, 190, ST101UB |
Product
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2937-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.