Device recall
Z-0584-2026: The LeadCare II Blood Lead Test System relies on electrochemistry and a unique…
FDA device recall · Class II · Magellan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0584-2026 |
|---|---|
| Recall event | 97858 |
| Product | The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48… |
| Product code | DOF |
| Recalling firm | Magellan Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K052549 |
| FEI number | 1218996 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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