Facility

Trinity Biotech USA

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	1318354
Establishment type	Manufacture Device in the United States for Export Only
Location	2823 Girts Rd Jamestown, NY, US 14701
Registration status	Active · expires 2026
Parent company	TRINITY BIOTECH, PLC (owner-operator 9025161)
Brand names	Trinity Biotech Uni-Gold Syphilis Treponemal Control Kit; Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit; Trinity Biotech Captia Syphilis IgM ELISA Test Kit; BioRad Syphilis Total Antibody ELISA Test Kit; Trinity Biotech Captia Syphilis Total Antibody ELISA Test Kit; BioRad Syphilis IgM ELISA Test Kit; Captia Syphilis Total Antibody ELISA Test Kit

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Product code LIP (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3830

Recalls & enforcement

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

FDA inspections (1)

VAI2017-09-01
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “Trinity Biotech USA (FEI 1318354) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1318354-trinity-biotech-usa/

Not open yet

Alerts for Trinity Biotech USA

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.