ProNephro AKI (NGAL) Reagent Kit (100 tests) recall
Bioporto Diagnostics A/S recalled ProNephro AKI (NGAL) Reagent Kit (100 tests) on August 19, 2026 because of 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. It was sold in Worldwide - The affected product distribution included the United States and the countrie….
Why it was 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's recalled
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Quantity: 400 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Bioporto Diagnostics A/S, Hellerup
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Worldwide - The affected product distribution included the United States and the countrie…
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. - Status
- Ongoing
- Recall number
- Z-2937-2026
- Source
- U.S. Food and Drug Administration
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