FDA Medical devices recall ·
ProNephro AKI (NGAL) Reagent Kit (100 tests) recall
- Recall number
- Z-2937-2026
- Date
- (initiated May 18, 2026)
- Company / brand
- Bioporto Diagnostics A/S
Tuborg Havnevej 15, St, Hellerup, Denmark - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 400 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2937-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.