Device recall
Z-3041-2020: Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description)…
FDA device recall · Class II · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-3041-2020 |
|---|---|
| Recall event | 86335 |
| Product | Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 " |
| Product code | LDJ |
| Recalling firm | Ameditech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2024 |
| FEI number | 3003789989 |
At a glance
- None 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