Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
FDA Recall Z-2292-2025 · Posted 2025-08-12
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Recalling FirmTrinity Biotech USA
Recall StatusOpen, Classified
Product CodeMJH
Date Initiated2025-07-22
Product Quantity968 kits
Reason for Recall
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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