Reported Aug 19, 2026 · Ongoing · Updated Sep 16, 2026
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bioporto Diagnostics A/S · Tuborg Havnevej 15, St · Hellerup
Is this the product you have?
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Lot codes and dates
- Model numberST101UB / 08787174 190
- GTIN code5711435000156
- Lot-number04909125 and 04912125
- Amount recalled
- 400 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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