Device recall
Z-0053-2014: Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control…
FDA device recall · Class III · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-0053-2014 |
|---|---|
| Recall event | 66394 |
| Product | Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys… |
| Product code | DIF |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 26, 2014 |
| 510(k) numbers | K060788 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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