Device recall
Z-3084-2017: Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include…
FDA device recall · Class III · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-3084-2017 |
|---|---|
| Recall event | 77702 |
| Product | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to… |
| Product code | LFH |
| Recalling firm | Ameditech Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 6, 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