Device recall
Z-1183-2018: Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended…
FDA device recall · Class II · Quidel Corporation
Key facts
| Recall number (Z-number) | Z-1183-2018 |
|---|---|
| Recall event | 79271 |
| Product | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use. |
| Product code | PSZ |
| Recalling firm | Quidel Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2019 |
| 510(k) numbers | K162438, K162911 |
| FEI number | 2024674 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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