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Bioporto Diagnostics A/S Recalls

1 recall on record · August 19, 2026 to August 19, 2026 · Medical Devices

August 19, 2026Medical DevicesFDA

Bioporto Diagnostics A/S recalls ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

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.