Trinity Biotech USA recalls Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnost…

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

Trinity Biotech initially notified consignees 06/05/2025 via letter. Consignees were instructed to inspect the conjugate bottles before use in both manual and automated testing and if any are observed with particulate matter, Trinity Biotech confirms the kit performs, and results are consistent with release specifications and IFU claims. However, replacement can be requested. Trinity Biotech notified consignees again on about 07/22/2025 via an updated URGENT: MEDICAL DEVICE Notification letter. Consignees were instructed that their trained laboratory technicians should inspect the conjugate bottles before use in both manual and automated testing, if any bottle is observed to contain conjugate with particulate matter, to discard the bottle and use a clear bottle available. If there are no other available clear bottles, please contact Trinity Biotech for a replacement kit. The current conjugate will be replaced with Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 067 once available.

• FDA enforcement recordOfficial FDA database entry for Z-2292-2025
• FDA 510(k) clearance · K991074The device's official FDA premarket clearance record
• FDA device classification · MJHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Trinity Biotech USASearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.