Drug recall
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the…
FDA recall event 97117 · Class II · Trinity Biotech USA
Key facts
| Event ID | 97117 |
|---|---|
| Recall numbers | Z-2292-2025 |
| Recalling firm | Trinity Biotech USA |
| Product type | Devices |
| Products | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. |
| Initiation date | Jul 22, 2025 |
| Report date | Aug 20, 2025 |
| City | Jamestown |
| State | NY |
| Country | United States |
| FEI number | 1318354 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: