ProNephro AKI (NGAL) Reagent Kit
Bioporto recalls ProNephro AKI (NGAL) Reagent Kit over non-validated rework that could cause missed renal disease diagnosis.
Stop using the ProNephro AKI (NGAL) Reagent Kit and contact Bioporto Diagnostics A/S for instructions on returning the affected product and obtaining a replacement or further guidance.
Recall at a glance
- Quantity recalled
- 400 units
Why it was recalled
Bioporto Diagnostics A/S is recalling the ProNephro AKI (NGAL) Reagent Kit, an in vitro diagnostic test system for acute kidney injury, because a non-validated rework process for assay reagents could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Lot code
- 04909125, 04912125
- UDI-DI
- 08787174, 5711435000156, 04909125, 04912125
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification