FDAFDA · Food and drugs·Recall number Z-2937-2026
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Published August 19, 2026 · Recall initiated: May 18, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bioporto Diagnostics A/S
- Distributor
- 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.
- Lot
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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