Device recall
Z-2358-2016: Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433…
FDA device recall · Class I · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-2358-2016 |
|---|---|
| Recall event | 74665 |
| Product | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination… |
| Product code | GJS |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 20, 2017 |
| 510(k) numbers | K110212 |
| 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