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Bioporto Diagnostics A/S recalls ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Recalled August 19, 2026 · FDA recall Z-2937-2026 · Bioporto Diagnostics A/S
Hazard
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. · FDA Class II
Units
400 units
Sold at
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.
Description
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.
Manufacturer(s)
Bioporto Diagnostics A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →