---
title: "ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test Sy... — FDA record Z-2937-2026 | Is It on Recall"
description: "The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappr"
url: https://isitonrecall.com/recall/fda-device-z-2937-2026-pronephro-aki-ngal-reagent-kit-100-tests-ivd-acute-kidney-injury-test-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. — FDA record Z-2937-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 18, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
- **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.
- **Classification**: Class II
- **Recalling firm**: Bioporto Diagnostics A/S
- **Quantity**: 400 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2937-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2937-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125. |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Aug 19, 2026
- **Recall initiation date**: May 18, 2026
- **Center classification date**: Aug 12, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2937-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Bioporto Diagnostics A/S records](https://isitonrecall.com/brand/bioporto-diagnostics-a-s/)