Reported Aug 20, 2025 · Ongoing
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive…
Trinity Biotech USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trinity Biotech USA · 2823 Girts Rd · Jamestown, NY · 14701-9666
Is this the product you have?
- Bartels ELISA Legionella Urinary Antigen
- Model NumberB1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease
- Lot codes and dates
- Model NumberB1029-440
- UDI-DI05391516744065
- Lot Numbers065 and 066
- Amount recalled
- 968 kits
Where it was sold
Why it was recalled
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
This product could cause temporary or reversible health problems — stop using it.
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