Device recall
Z-1349-2020: RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041…
FDA device recall · Class II · Randox Laboratories, Limited
Key facts
| Recall number (Z-number) | Z-1349-2020 |
|---|---|
| Recall event | 84649 |
| Product | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories. |
| Product code | JJE |
| Recalling firm | Randox Laboratories, Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2021 |
| 510(k) numbers | K131554 |
| FEI number | 1000361607 |
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