Facility

THERAKOS DEVELOPMENT LIMITED

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)	3036773437
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	Suite 1 Plaza 211, Blanchardstown Corporate Park 2 Blanchardstown Dublin(County), IE D15 AP2D
Registration status	Active · expires 2026
Parent company	Therakos Development Limited (owner-operator 10092738)
Brand names	THERAKOS CELLEX

Activity by year

Recalls (1)

Devices registered here (1)

System, Photopheresis, Extracorporeal
Product code LNR (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2025-05-16
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.

All facilities operated by Therakos Development Limited

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. “THERAKOS DEVELOPMENT LIMITED (FEI 3036773437) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3036773437-therakos-development-limited/

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