Device recall
Z-0285-2019: Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of…
FDA device recall · Class II · Magellan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0285-2019 |
|---|---|
| Recall event | 81074 |
| Product | Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh… |
| Product code | DOF |
| Recalling firm | Magellan Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K052549, K971640 |
| 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