FDAFDA · Food and drugs·Recall number Z-2292-2025
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Published August 20, 2025 · Recall initiated: July 22, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trinity Biotech USA
- Distributor
- Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
- Lot
- Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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