Bioporto Diagnostics A/S recalls

Recall found. Bioporto Diagnostics A/S is named in FDA Class II recall Z-2937-2026 covering ProNephro AKI (NGAL) Reagent Kit (100 tests). 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.. Status: Ongoing.

Models with recalls

ProNephro AKI (NGAL) Reagent Kit (100 tests) (1)

All Bioporto Diagnostics A/S recalls

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…

Official ID Z-2937-2026 · Official record ↗

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