FDAHealthJuly 22, 2025
Trinity Biotech USA — Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
⚠️ Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 22, 2025
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
What's affected?
- 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.
- Brand
- Trinity Biotech USA
- Lot code
- 065
Additional details
Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 968 kits.
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