Device recall
Z-2962-2020: Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage…
FDA device recall · Class II · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-2962-2020 |
|---|---|
| Recall event | 86236 |
| Product | Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX… |
| Product code | CFJ |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2020 |
| 510(k) numbers | K970684 |
| FEI number | 1000361607 |
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