Device recall
Z-2292-2025: Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro…
FDA device recall · Class II · Trinity Biotech USA
Key facts
| Recall number (Z-number) | Z-2292-2025 |
|---|---|
| Recall event | 97117 |
| 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. |
| Product code | MJH |
| Recalling firm | Trinity Biotech USA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K991074 |
| FEI number | 1318354 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database