Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2292-2025 — Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.

U.S. FDA — Device Enforcement · United States · 2025-07-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2292-2025
Date of alert
2025-07-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Trinity Biotech USA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05391516744065
Reported risk: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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