Facility

TRINITY BIOTECH, PLC

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)	3002546385
Establishment type	Manufacture Medical Device
Location	IDA BUSINESS PARK BRAY Wicklow, IE --
Registration status	Active · expires 2026
Parent company	TRINITY BIOTECH, PLC (owner-operator 9025161)
Brand names	Trinity Biotech

Activity by year

Recalls (1)

Devices registered here (1)

Radioassay, Angiotensin Converting Enzyme
Product code KQN (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1090

Recalls & enforcement

Class IIOngoing2025-07-22
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

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. “TRINITY BIOTECH, PLC (FEI 3002546385) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002546385-trinity-biotech-plc/

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