Device recall
Z-1158-04: RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro…
FDA device recall · Class II · PerkinElmer LAS Inc
Key facts
| Recall number (Z-number) | Z-1158-04 |
|---|---|
| Recall event | 29485 |
| Product | RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use. |
| Product code | JBD |
| Recalling firm | PerkinElmer LAS Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2008 |
| 510(k) numbers | K840011 |
| FEI number | 1522510 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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