FDAFDA recall Z-2937-2026 · Aug 19, 2026
Bioporto Diagnostics A/S: ProNephro AKI (NGAL) Reagent Kit (100 tests) recall
Recall found
Product
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Reason for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- Quantity
- 400 units
- Distribution
- 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.
- Recalling firm
- Bioporto Diagnostics A/S, Hellerup
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-18
Source: openFDA enforcement record Z-2937-2026 · search recall number Z-2937-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.