FDA Device recall Z-2292-2025
Bartels ELISA Legionella Urinary Antigen
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Bartels ELISA Legionella Urinary Antigen by Trinity Biotech Usa, citing potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2292-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-22 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Trinity Biotech Usa |
| Distribution | US |
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
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Identifiers
| code_info | Model Number: B1029-440. UDI-DI: 05391516744065. Lot Numbers: 065 and 066 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2292-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.