Facility

BIOPORTO DIAGNOSTICS A/S

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010739981
Establishment type	Manufacture Medical Device
Location	Tuborg Havnevej Hellerup Hovedstaden, DK 2900
Registration status	Active · expires 2026
Parent company	BioPorto Diagnostics A/S (owner-operator 10089659)
Brand names	ProNephro AKI (NGAL)

Activity by year

Recalls (1)

Devices registered here (1)

Acute Kidney Injury Test System
Product code PIG (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1220

Recalls & enforcement

Class IIOngoing2026-05-18
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.

All facilities operated by BioPorto Diagnostics A/S

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BIOPORTO DIAGNOSTICS A/S (FEI 3010739981) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010739981-bioporto-diagnostics-a-s/

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