Device recall
Z-0311-2016: iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel…
FDA device recall · Class II · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-0311-2016 |
|---|---|
| Recall event | 72471 |
| Product | iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel… |
| Product code | JXM |
| Recalling firm | Ameditech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2016 |
| 510(k) numbers | K052115 |
| FEI number | 3003789989 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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