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Open, Classified

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

FDA Recall Z-2937-2026 · Posted 2026-08-12

Recalling FirmBioporto Diagnostics A/S
Recall StatusOpen, Classified
Product CodePIG
Date Initiated2026-05-18
Product Quantity400 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232761ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc. · 2023-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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