Device recall
Z-0047-05: RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life…
FDA device recall · Class III · PerkinElmer LAS Inc
Key facts
| Recall number (Z-number) | Z-0047-05 |
|---|---|
| Recall event | 30017 |
| Product | RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit. |
| Product code | GKA |
| Recalling firm | PerkinElmer LAS Inc |
| Recall class | Class III |
| 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
- 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