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FDA (Device enforcement)Recalled 2025-07-22class ii

Trinity Biotech USA: Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.

Hazard

Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

Details from the source

Reason for recall: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. 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 Lot/code info: Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066

UPC codes

05391516744065

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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