Device recall
Z-0882-2015: INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System…
FDA device recall · Class I · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-0882-2015 |
|---|---|
| Recall event | 69964 |
| Product | INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere… |
| Product code | GJS |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 18, 2017 |
| 510(k) numbers | K072727 |
| 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