Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test ki...
FDA Recall #Z-2292-2025 — Class II — July 22, 2025
Product Description
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Reason for Recall
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Recalling Firm
Trinity Biotech USA — Jamestown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
968 kits
Distribution
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Code Information
Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated