Device recall
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Recall number
- Z-2937-2026
- Event id
- 99266
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Bioporto Diagnostics A/S
- Report date
- Aug 19, 2026
- Initiated
- May 18, 2026
- Center classification date
- Aug 12, 2026
- 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.
- Quantity
- 400 units
- Code info
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Hellerup, Denmark