FDA recall, , Moderate risk
ProNephro AKI (NGAL) Reagent Kit
The ProNephro AKI (NGAL) Reagent Kit may lead to missed diagnosis of renal disease.
Summary by Recall Canary from the FDA notice
What happened
Bioporto Diagnostics A/S, located in Hellerup, Denmark, recalled the ProNephro AKI (NGAL) Reagent Kit (100 tests), an IVD Acute Kidney Injury Test System, because the use of 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.
The recall began May 18, 2026, and was added to the FDA's Enforcement Report on August 12, 2026. The affected product was distributed worldwide, including the United States, European Union countries, Chile, and Hong Kong; no affected product was distributed to Canada, though Health Canada was notified.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- UDI-DI
- 08787174
- 5711435000156
- 04909125
- 04912125
Recall details
- Company began the recall
- Sold in
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.
- Company
- Bioporto Diagnostics A/SHellerup, Denmark
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99266
- Recall number
- Z-2937-2026
- Quantity recalled
- 400 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
