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Bioporto Diagnostics A/S

Country not established

Part of BioPorto Diagnostics A/S

Devices
6
FDA recalls
11 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Bioporto Diagnostics A/S makes

The company produces in vitro diagnostic (IVD) reagents, controls, and calibrators for measuring Neutrophil gelatinase-associated lipocalin (NGAL) in blood samples. These products are designed to support the detection and monitoring of acute kidney injury (AKI), including the ProNephro AKI™ series for clinical laboratory use. The portfolio includes specific kits for reagent, control, and calibrator applications to ensure accurate NGAL testing.

The NGAL-related IVD products are classified under FDA’s regulatory framework as Class I and Class II devices, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for in vitro diagnostics.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

Company details

DUNS number
586925158
Phone
+4545290000

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Bioporto Diagnostics A/S, initiated on 2026-05-18. By recorded status: 1 ongoing. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 1

  • 2026

    • 18 May 2026 Z-2937-2026 Class II Ongoing 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. Distribution: Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and…
      Full distribution text 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.
      Submission number: K232761

Frequently asked questions

How many devices does Bioporto Diagnostics A/S have in the registry?

The registry currently lists 6 devices for Bioporto Diagnostics A/S. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bioporto Diagnostics A/S's devices?

Among its 6 most recently registered devices, Bioporto Diagnostics A/S has devices listed in FDA GUDID (6 devices).

What risk classes do Bioporto Diagnostics A/S's devices fall under?

Among its 6 most recently registered devices, the classes recorded for Bioporto Diagnostics A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Bioporto Diagnostics A/S?

FDA recall records list 1 recall initiated by Bioporto Diagnostics A/S, the most recent initiated on 2026-05-18. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Bioporto Diagnostics A/S in the registry?

The most recently registered devices listed for Bioporto Diagnostics A/S include ProNephro AKI™ (NGAL) Reagent Kit ST101UB, ProNephro AKI™ (NGAL) Control Kit ST103UA and ProNephro AKI™ (NGAL) Calibrator Kit ST102UA.

Generated automatically from registry data and not verified by a human reviewer.