Trinity Biotech recalls Bartels ELISA Legion: Legionella Urinary Antigen test kits (model B1029-440, lots 065-066) due to potential particulate matter. Consumers should check their kit's lot number and contact the company for details.
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Trinity Biotech is recalling Bartels ELISA Legionella Urinary Antigen test kits (model B1029-440) with lot numbers 065 and 066 because they may contain particulate matter. This could affect test accuracy and lead to incorrect results if used.
The test kits may contain particulate matter, which could cause inaccurate test results. This might lead to false negatives or positives, meaning incorrect conclusions about Legionnaires disease.
People who purchased or use the Bartels ELISA Legionella Urinary Antigen test kits (model B1029-440) with lot numbers 065 or 066 are affected. Those testing for Legionnaires disease are most at risk of inaccurate results.
Check the lot number on the kit's packaging. The affected kits have model number B1029-440 and lot numbers 065 or 066. These were sold as in vitro diagnostic test kits for Legionnaires disease.
Look for the lot number on the kit's packaging; affected kits have lot numbers 065 or 066.
The model number is B1029-440.
Lot numbers 065 and 066 are affected.
The recall record does not specify a remedy, so contact Trinity Biotech for further instructions.
We’ve drafted a message you can send Trinity Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-2292-2025 — Trinity Biotech Trinity Biotech Hello, I own a Trinity Biotech that is covered by recall Z-2292-2025 from Trinity Biotech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
