Device recall
Z-2439-2018: AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF…
FDA device recall · Class II · Opgen Inc
Key facts
| Recall number (Z-number) | Z-2439-2018 |
|---|---|
| Recall event | 80301 |
| Product | AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC… |
| Product code | LJG |
| Recalling firm | Opgen Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2019 |
| FEI number | 3007065145 |
At a glance
- None 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