Device recall
Z-1954-2021: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
FDA device recall · Class I · Magellan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1954-2021 |
|---|---|
| Recall event | 87992 |
| Product | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 |
| Product code | DOF |
| Recalling firm | Magellan Diagnostics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 24, 2023 |
| 510(k) numbers | K123563 |
| 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