Device recall
Z-1893-2026: (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit…
FDA device recall · Class II · Magellan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1893-2026 |
|---|---|
| Recall event | 98502 |
| Product | (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the… |
| 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