Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Reported: August 20, 2025 Initiated: July 22, 2025 #Z-2292-2025
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.
Reason for Recall
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Details
- Recalling Firm
- Trinity Biotech USA
- Units Affected
- 968 kits
- Distribution
- Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
- Location
- Jamestown, NY
Frequently Asked Questions
What product was recalled? ▼
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.. Recalled by Trinity Biotech USA. Units affected: 968 kits.
Why was this product recalled? ▼
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2292-2025.
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