Device recall
Z-2226-2017: Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage…
FDA device recall · Class I · Magellan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-2226-2017 |
|---|---|
| Recall event | 77211 |
| Product | Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment… |
| Product code | DOF |
| Recalling firm | Magellan Diagnostics, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 8, 2021 |
| 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