Device recall
Z-1786-2024: Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative…
FDA device recall · Class III · Randox Laboratories Ltd.
Key facts
| Recall number (Z-number) | Z-1786-2024 |
|---|---|
| Recall event | 94371 |
| Product | Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115 |
| Product code | JJE |
| Recalling firm | Randox Laboratories Ltd. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K220451 |
| 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