Device recall
Z-1328-2019: CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10…
FDA device recall · Class II · Opgen Inc
Key facts
| Recall number (Z-number) | Z-1328-2019 |
|---|---|
| Recall event | 82665 |
| Product | CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides… |
| Product code | LJG |
| Recalling firm | Opgen Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 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