Device recall
Z-0588-2017: Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the…
FDA device recall · Class II · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-0588-2017 |
|---|---|
| Recall event | 75443 |
| Product | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate… |
| Product code | JJY |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2017 |
| 510(k) numbers | K072892 |
| 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