Device recall
Z-0779-2017: DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
FDA device recall · Class III · PerkinElmer Health Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-0779-2017 |
|---|---|
| Recall event | 75708 |
| Product | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum |
| Product code | CGJ |
| Recalling firm | PerkinElmer Health Sciences, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 5, 2017 |
| 510(k) numbers | K862043 |
| FEI number | 3006159931 |
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