Device recall
Z-1214-2014: Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400…
FDA device recall · Class II · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-1214-2014 |
|---|---|
| Recall event | 67529 |
| Product | Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the… |
| Product code | DJR |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2014 |
| 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