Facility

Gentian AS

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)	3006801241
Establishment type	Manufacture Medical Device
Location	Bjornasveien 5 Moss Ostfold, NO N-1596
Registration status	Active · expires 2026
Parent company	Gentian AS (owner-operator 10023325)
Brand names	Cystatin C Immunoassay

Activity by year

Recalls (1)

Devices registered here (1)

Test, Cystatin C
Product code NDY (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1225

Recalls & enforcement

Class IITerminated2020-09-02
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.

All facilities operated by Gentian AS

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. “Gentian AS (FEI 3006801241) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006801241-gentian-as/

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