Device recall
Z-1446-2012: Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25…
FDA device recall · Class II · Alere San Diego dba Biosite Innovacon Hemosense Inc
Key facts
| Recall number (Z-number) | Z-1446-2012 |
|---|---|
| Recall event | 61637 |
| Product | Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug… |
| Product code | DJR |
| Recalling firm | Alere San Diego dba Biosite Innovacon Hemosense Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2012 |
| 510(k) numbers | K060791 |
| FEI number | 1000125596 |
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