Device recall
Z-3035-2017: LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product…
FDA device recall · Class II · Magellan Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-3035-2017 |
|---|---|
| Recall event | 77695 |
| Product | LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The… |
| Product code | DOF |
| Recalling firm | Magellan Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 21, 2018 |
| 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