Reported Aug 20, 2025 · Ongoing

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive…

Trinity Biotech USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trinity Biotech USA · 2823 Girts Rd · Jamestown, NY · 14701-9666

Is this the product you have?

  • Bartels ELISA Legionella Urinary Antigen
  • Model NumberB1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease
Lot codes and dates
  • Model NumberB1029-440
  • UDI-DI05391516744065
  • Lot Numbers065 and 066
Amount recalled
968 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.