Device recall
Z-2143-2012: SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51…
FDA device recall · Class II · SCC Soft Computer
Key facts
| Recall number (Z-number) | Z-2143-2012 |
|---|---|
| Recall event | 62023 |
| Product | SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to… |
| Product code | JQP |
| Recalling firm | SCC Soft Computer |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2014 |
| FEI number | 1000307651 |
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