Bartels ELISA Legionella Urinary Antigen — Class II medical device recall Z-2292-2025
Ongoing recall by Trinity Biotech USA, reported 2025-08-20, distributed nationwide. Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate ma
| Recall number | Z-2292-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trinity Biotech USA, Jamestown, NY, United States |
| Recall initiated | 2025-07-22 |
| Classified | 2025-08-12 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, GB, IE, IL, KW, LV |
| Quantity | 968 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 05391516744065 |
| Lot numbers | 065, 066 |
| Model numbers | B1029-440 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2292-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.