Device recall
Z-1101-2017: Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product…
FDA device recall · Class III · PerkinElmer Health Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-1101-2017 |
|---|---|
| Recall event | 75949 |
| Product | Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used… |
| Product code | KHO |
| Recalling firm | PerkinElmer Health Sciences, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 3, 2018 |
| 510(k) numbers | K935047 |
| FEI number | 3006159931 |
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