Recall Z-2292-2025— Trinity Biotech USA

Name: FDA recall Z-2292-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-22

Class II · Ongoing

Class II FDA medical device recall by Trinity Biotech USA, initiated 2025-07-22. It names one FDA 510(k) clearance: K991074. Product: 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: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter..

Recalling firm: Trinity Biotech USA
Classification: Class II
Status: Ongoing
Initiated: 2025-07-22
Firm location: Jamestown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTIntracel Corp.·cleared 1999-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.