Facility

Fujirebio Europe N.V.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3002608770
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	TECHNOLOGIEPARK 6 GHENT Oost-Vlaanderen, BE B-9052
Registration status	Active · expires 2026
Parent company	Fujirebio Diagnostics, Inc. (owner-operator 10022860)
Brand names	ARCHITECT Thyroglobulin Controls; Alinity i CYFRA 21-1 Controls (China); Lumipulse B-Amyloid Plasma Controls; ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens; ARCHITECT Methotrexate Extended Range Controls (ROW); Atellica IM Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens; Beckman PK-CMV PA Controls; Lumipulse ? Amyloid Controls; Lumipulse G BRAHMS PCT Controls; Alinity i CYFRA 21-1 Controls (ROW); ARCHITECT CYFRA 21-1 Controls; Alinity i Methotrexate Extended Range Controls (ROW)

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660

Recalls & enforcement

Class IIOngoing2025-12-11
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated ind…

FDA inspections (1)

NAI2019-06-06
No Action Indicated · Project Evaluation: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “Fujirebio Europe N.V. (FEI 3002608770) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002608770-fujirebio-europe-n-v/

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