Device recall
Z-3030-2020: Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description)…
FDA device recall · Class II · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-3030-2020 |
|---|---|
| Recall event | 86335 |
| Product | Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip… |
| Product code | DIO |
| Recalling firm | Ameditech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2024 |
| 510(k) numbers | K082508 |
| FEI number | 3003789989 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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