Official recall notice

FDA DeviceClass IINotable

ProNephro AKI Reagent Kit Recall (Aug 2026)

Product: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

Recall date
2026-08-19
FDA class
Class II

Why it was recalled

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.

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Product description

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.

Affected products

Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.

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