Bioporto Diagnostics A/S Recalls

1 recall on record in the United States

medical: 1
medical Class II
2026-08-19

Bioporto Diagnostics A/S recalls ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidn

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.

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