Bioporto ProNephro AKI kit recalled for unvalidated reagent rework
Bioporto Diagnostics recalled certain lots of the ProNephro AKI (NGAL) Reagent Kit, a test used to help detect acute kidney injury. The reagents were reworked using a process that had not been validated, which could lead to missed kidney disease, incorrect treatment decisions, or inappropriate monitoring. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether your kit's model number ST101UB and lot number 04909125 or 04912125 match the recall.
- Stop using kits from the affected lots.
- Contact Bioporto Diagnostics or your supplier for return and remedy instructions.
- Talk to your healthcare provider if results from affected lots were used in patient care decisions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 400 units
- Illnesses reported
- None reported
- Manufactured in
- Tuborg Havnevej 15, St, Hellerup, Denmark
- Classification
- Class II
- Recall number
- Z-2937-2026
In the FDA's words
- Description
- 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. Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. Distribution: 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. Affected quantity: 400 units
- 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.