Bioporto Diagnostics A/S recalls ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
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.
Read the official notice →- Date
- 2026-08-19
- Country
- United States
- Brand
- Bioporto Diagnostics A/S
- Product
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Classification
- Class II
- Units
- Worldwide - The affected product distribution included the United States and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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