FDA Medical devices recall ·
Bartels ELISA Legionella Urinary Antigen recall
- Recall number
- Z-2292-2025
- Date
- (initiated July 22, 2025)
- Company / brand
- Trinity Biotech USA
2823 Girts Rd, Jamestown, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 968 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
Distribution
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2292-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.