FDA recall Z-2292-2025

Product

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.

Distribution

Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.

Key facts

Status

Ongoing

Initiation date

2025-07-22

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jamestown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2025