Device recall
Z-2362-2016: Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1…
FDA device recall · Class I · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-2362-2016 |
|---|---|
| Recall event | 74665 |
| Product | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it… |
| Product code | GJS |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 20, 2017 |
| 510(k) numbers | K092987 |
| 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