← FDA ENFORCEMENT
Z-2937-2026Class II

Bioporto Diagnostics A/S

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Bioporto Diagnostics A/S
Product type
Device
Status
Ongoing
Report date
2026-08-19
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 quantity
400 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Product description

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

Code / lot info

Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.

Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →