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

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.

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

A Quality Notification dated 6/3/26 was sent to consignees via email notifying them of the recall. Consignees in the US are to coordinate replacement of devices. ROW Consignees are to scrap unopened kits in accordance with local requirements and request replacements.

• FDA enforcement recordOfficial FDA database entry for Z-2937-2026
• FDA 510(k) clearance · K232761The device's official FDA premarket clearance record
• FDA device classification · PIGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Bioporto Diagnostics A/SSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.