Device recall
Z-0603-2012: The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated…
FDA device recall · Class II · PerkinElmer LAS, Inc
Key facts
| Recall number (Z-number) | Z-0603-2012 |
|---|---|
| Recall event | 60390 |
| Product | The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids… |
| Product code | JLW |
| Recalling firm | PerkinElmer LAS, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2012 |
| 510(k) numbers | K090846 |
| 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