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Bioporto Diagnostics A/S: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

Medical DevicesSource: FDA (device) · Date: 2026-08-19

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Bioporto Diagnostics A/S
Product
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-05-18
Code info
Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
Product quantity
400 units
Voluntary mandated
Voluntary: Firm initiated
City
Hellerup
Country
Denmark
Event id
99266
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