Device recall
Z-2059-2018: RX Imola (RX4900) For Professional Use for the quantitative in vitro…
FDA device recall · Class II · Randox Laboratories
Key facts
| Recall number (Z-number) | Z-2059-2018 |
|---|---|
| Recall event | 79968 |
| Product | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. |
| Product code | JJE |
| Recalling firm | Randox Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2020 |
| 510(k) numbers | K052914 |
| FEI number | 3003059701 |
At a glance
- 1–9 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