Device recall
Z-1107-2017: Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended…
FDA device recall · Class II · PerkinElmer Life and Analytical Sciences, Wallac, OY
Key facts
| Recall number (Z-number) | Z-1107-2017 |
|---|---|
| Recall event | 76165 |
| Product | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. |
| Product code | KHO |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2017 |
| 510(k) numbers | K090846 |
| FEI number | 3002808498 |
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