Device recall
Z-1905-2009: Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and…
FDA device recall · Class II · Perkin Elmer
Key facts
| Recall number (Z-number) | Z-1905-2009 |
|---|---|
| Recall event | 51336 |
| Product | Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. |
| Product code | JQP |
| Recalling firm | Perkin Elmer |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2011 |
| 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