Device recall
Z-0043-2008: ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2…
FDA device recall · Class III · Esa Biosciences, Inc.
Key facts
| Recall number (Z-number) | Z-0043-2008 |
|---|---|
| Recall event | 44909 |
| Product | ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142 |
| Product code | DOF |
| Recalling firm | Esa Biosciences, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 25, 2008 |
| 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