FDA Enforcement
Class II
Ongoing
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Recall: Z-2292-2025
·
Reported August 20, 2025
Enforcement
- Recall Number
- Z-2292-2025
- Event ID
- 97117
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Trinity Biotech USA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 20, 2025
- Initiation Date
- July 22, 2025
- Classification Date
- August 12, 2025
- Address
- 2823 Girts Rd, N/A, Jamestown, NY, 14701-9666, United States
Description
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Reason
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Code Info
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.
Quantity
968 kits