ProNephro AKI (NGAL) Reagent Kit (100 tests): recall status

Notice names this product. Bioporto Diagnostics A/S’s ProNephro AKI (NGAL) Reagent Kit (100 tests) is named in FDA Class II recall Z-2937-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Identifying details: Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.. Units affected: 400 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: ProNephro AKI (NGAL) Reagent Kit (100 tests)
Company / brand: Bioporto Diagnostics A/S
Lot / serial / date codes: 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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Bioporto Diagnostics A/S

Recalls naming this model

FDA Class II · Medical device · August 19, 2026

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

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 o…

Company / brand: Bioporto Diagnostics A/S

Affected product: ProNephro AKI (NGAL) Reagent Kit (100 tests)

Official ID Z-2937-2026 · Official record ↗

See all Bioporto Diagnostics A/S recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.