ProNephro AKI recall (Bioporto Diagnostics A/S)
Medical deviceClass IIOngoing
Summary: Bioporto Diagnostics A/S is recalling ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.. Reason: 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 is being recalled
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2937-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 18, 2026 |
| Reported | August 19, 2026 |
| Company | Bioporto Diagnostics A/S |
| Company location | Hellerup, Denmark |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 400 units |
More recalls from Bioporto Diagnostics A/S · all medical device recalls · recalls from May 2026