Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Recalled by Trinity Biotech USA Due to Potential for Bartels ELISA Legionella Urinary Antigen kit...

Date: July 22, 2025
Company: Trinity Biotech USA
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Trinity Biotech USA directly.

Affected Products

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.

Quantity: 968 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Trinity Biotech USA

Trinity Biotech USA has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report