Device recall
Z-0902-2017: Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software…
FDA device recall · Class II · PerkinElmer Health Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-0902-2017 |
|---|---|
| Recall event | 75817 |
| Product | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate… |
| Product code | JQP |
| Recalling firm | PerkinElmer Health Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2017 |
| FEI number | 3006159931 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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