Official recall notice
FDA DeviceClass IINotable
FDA Recall: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Recall date
- 2026-08-19
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
400 units
Product description
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.