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TRU Legionella

MERIDIAN BIOSCIENCE, INC. · Model 751930 · UDI-DI 00840733101267

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510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia.

Recalls

Date	Firm	Reason
2025-07-22	Trinity Biotech USA	Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
2021-10-11	Clark Laboratories, Inc.	Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
2006-09-29	Inverness Medical Professional Diagnostics	Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.