OVERLOOKED

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Class IIOngoing

Bioporto Diagnostics A/S recalls ProNephro AKI (NGAL) Reagent Kit (100 tests)

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Bioporto Diagnostics A/S
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99266…

Products

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

    Codes/lots: Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.Quantity: 400 unitsRecall no. Z-2937-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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