Trinity Biotech USA: Device Recall
Recall #Z-2292-2025 · 07/22/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2292-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Trinity Biotech USA
- Status
- Ongoing
- Date Initiated
- 07/22/2025
- Location
- Jamestown, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 968 kits
Reason for Recall
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Product 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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.