Trinity Biotech USA: Medical Device Recall in 2025 - (Recall #: Z-2292-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 22, 2025

Date Posted: August 20, 2025

Recall Number: Z-2292-2025

Event ID: 97117

Reason for Recall:

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

Status: Ongoing

Product Quantity: 968 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated