Device 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.
Z-2292-2025
Product summary
- Event
- Event 97117
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 968 kits
- Official record key
device-enforcement:Z-2292-2025
Official wording
Reason: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Code information: Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066
Distribution pattern: Worldwide - US Nationwide distribution in the states of Maryland and Utah. The countries of France, Germany, Ireland, Israel, Kuwait, Latvia, UK.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter