Device recall
Z-2356-2016: Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT…
FDA device recall · Class I · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-2356-2016 |
|---|---|
| Recall event | 74665 |
| Product | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by… |
| Product code | GJS |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 20, 2017 |
| 510(k) numbers | K020679 |
| 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