Device recall
Z-1542-2018: Alere iScreen Dx Urine Drug Screen Card
FDA device recall · Class III · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-1542-2018 |
|---|---|
| Recall event | 79549 |
| Product | Alere iScreen Dx Urine Drug Screen Card |
| Product code | LFH |
| Recalling firm | Ameditech Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 11, 2019 |
| 510(k) numbers | K022355 |
| FEI number | 3003789989 |
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