Device recall
Z-0300-2016: 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K; and 11 Panel Cup (OPI300)…
FDA device recall · Class II · Ameditech Inc
Key facts
| Recall number (Z-number) | Z-0300-2016 |
|---|---|
| Recall event | 72471 |
| Product | 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist… |
| 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