TRINITY BIOTECH, PLC
1 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (1)
Registered facilities (4)
- TRINITY BIOTECH, PLC FEI 3002546385 · IE
- Trinity Biotech USA FEI 1318354 · NY
- Trinity Biotech do Brasil FEI 3032069621 · BR
- Trinity Biotech (Primus Corporation dba Trinity Biotech) FEI 1931251 · MO
Recalls & enforcement
- Class IIOngoing2025-07-22Potential 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. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “TRINITY BIOTECH, PLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9025161-trinity-biotech-plc/
Alerts for TRINITY BIOTECH, PLC
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.
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.