Trinity Biotech USA has recalled 968 kits of the Bartels ELISA Legionella Urinary Antigen test (model B1029-440) because they may contain particulate matter. These kits are used in clinical laboratories to help provide a presumptive diagnosis of past or current Legionnaires' Disease. Only lot numbers 065 and 066 are included in this recall.
The presence of particulate matter in the test components can interfere with the assay's performance, potentially leading to incorrect diagnostic results or delayed treatment for patients suspected of having Legionnaires' Disease.
In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.