Z-2937-2026Class II

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

Name: Z-2937-2026 ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System
Creator: Bioporto Diagnostics A/S
Published: 2026-05-18
License: https://open.fda.gov/license/

Bioporto Diagnostics A/S / initiated 2026-05-18 / Open, Classified / root cause: manufacturing process

FDA source

Bioporto Diagnostics A/S began a recall of ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System on 2026-05-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2937-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-18
Posted: 2026-08-12
Recalling firm: Bioporto Diagnostics A/S
Product: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Product code: PIG Acute Kidney Injury Test System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 400 units
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.
Product codes and lots: Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2937-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2937-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-12

Product code PIG

K232761Class IIProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc. / cleared 2023-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)